FDA Product Code
FDA Product Code CIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1035
510(k) Clearances — 120 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251157 | Core Metabolic | Truvian Health | 2026-01-09 | Traditional | PDF ↗ |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | 2021-11-23 | Traditional | PDF ↗ |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | Medicon Hellas S.A | 2021-09-21 | Traditional | PDF ↗ |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 | Traditional | PDF ↗ |
| K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Biosystems S.A. | 2018-04-13 | Traditional | PDF ↗ |
| K131488 | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2013-08-19 | Traditional | PDF ↗ |
| K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-13 | Traditional | PDF ↗ |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | Polymedco, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH | Elitechgroup | 2011-06-21 | Traditional | PDF ↗ |
| K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT | Medica Corp. | 2011-04-04 | Traditional | PDF ↗ |
| K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT | Medica Corp. | 2009-02-20 | Traditional | PDF ↗ |
| K072143 | S40 CLINICAL ANALYZER, S TEST ALB | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-07-14 | Traditional | PDF ↗ |
| K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL | Horiba Abx | 2007-06-05 | Traditional | PDF ↗ |
| K033009 | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 | Roche Diagnostics Corp. | 2003-10-16 | Special | PDF ↗ |
| K030006 | ATAC PAK ALBUMIN REAGENT | Elan Diagnostics | 2003-03-07 | Traditional | PDF ↗ |
| K023875 | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 | Special | PDF ↗ |
| K022072 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS | Precision Systems, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 | Wiener Laboratories Saic | 2001-09-21 | Traditional | PDF ↗ |
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2001-06-25 | Special | PDF ↗ |
| K010877 | CHEMWELL, MODEL 2900 | Awareness Technology, Inc. | 2001-05-23 | Abbreviated | PDF ↗ |
| K003327 | ALBUMIN | Jas Diagnostics, Inc. | 2000-12-05 | Traditional | PDF ↗ |
| K992399 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-09-15 | Traditional | PDF ↗ |
| K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | 1999-06-30 | Traditional | PDF ↗ |
| K984494 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | 1999-03-23 | Traditional | PDF ↗ |
| K981758 | ALBG | Abbott Laboratories | 1998-06-12 | Traditional | PDF ↗ |
| K981468 | ALBG | Abbott Laboratories | 1998-05-27 | Traditional | PDF ↗ |
| K980041 | CARESIDE ALBUMIN | Exigent Diagnostics, Inc. | 1998-02-04 | Traditional | PDF ↗ |
| K971445 | ALB OR ALBUMIN | Carolina Liquid Chemistries Corp. | 1997-05-02 | Traditional | PDF ↗ |
| K955781 | ALBUMIN | Derma Media Lab., Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K952488 | TRACE COBAS MIRA RANGE | Trace Scientific , Ltd. | 1995-10-13 | Traditional | PDF ↗ |
| K946355 | DMA ALBUMIN PROCEDURE | Data Medical Associates, Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K943000 | ALBUMIN QVET | Prisma Systems | 1994-12-13 | Traditional | PDF ↗ |
| K935179 | EMDS ALBUMIN (ALB) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K924368 | OLYMPUS ALBUMIN REAGENT | Olympus Corp. | 1993-02-08 | Traditional | PDF ↗ |
| K923959 | ALBUMIN TEST | Em Diagnostic Systems, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K923322 | TRACE ALBUMIN-MR REAGENT | Trace Scientific , Ltd. | 1992-09-11 | Traditional | PDF ↗ |
| K922369 | OLYMPUS ALBUMIN REAGENT | Olympus Corp. | 1992-07-17 | Traditional | PDF ↗ |
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | Technicon Instruments Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K913920 | ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 | Em Diagnostic Systems, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K913195 | KODAK EKTACHEM DT SLIDES (ALB) | Eastman Kodak Company | 1991-08-26 | Traditional | PDF ↗ |
| K905660 | SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 | Em Diagnostic Systems, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K903543 | SYNERMED ALBUMIN REAGENT KIT | Synermed, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K901268 | COULTER ALBUMIN REAGENT | Coulter Corp. | 1990-05-30 | Traditional | PDF ↗ |
| K896235 | COBAS READY ALBUMIN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896910 | CLINISTAT ALBUMIN REAGENT TEST | Miles Diagnostics Div. | 1990-01-18 | Traditional | PDF ↗ |
| K893777 | ALBUMIN TEST (ALB) ITEM NUMBER: 65401 | Em Diagnostic Systems, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K891375 | IQ ALBUMIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-05 | Traditional | PDF ↗ |
| K885094 | BIOTROL ALBUMIN | Biotrol, USA, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884705 | ALBUMIN TEST (ALB) ITEM #65650 | Em Diagnostic Systems, Inc. | 1989-01-11 | Traditional | PDF ↗ |
| K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM | A-Kem, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K875207 | ALBUMIN CAT. # 201-03 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | Traditional | PDF ↗ |
| K880844 | ALBUMIN REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | Traditional | PDF ↗ |
| K880313 | WAKO(TM) AUTOKIT ALBUMIN | Wako Chemicals USA, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K875070 | ALBUMIN, BROMCRESOL GREEN DYE-BINDING | Tech-Co, Inc. | 1988-01-11 | Traditional | PDF ↗ |
| K874163 | ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Simmler, Inc. | 1987-10-29 | Traditional | PDF ↗ |
| K873994 | EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 | Em Diagnostic Systems, Inc. | 1987-10-29 | Traditional | PDF ↗ |
| K870372 | ALBUMIN REAGENT - BROMCRESOL GREEN METHOD | Trace Scientific , Ltd. | 1987-08-19 | Traditional | PDF ↗ |
| K864715 | EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 | Em Diagnostic Systems, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K863263 | ALBUMIN PROCEDURE | Data Medical Associates, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K863050 | ALBUMETER | J. D. Assoc. | 1986-09-11 | Traditional | PDF ↗ |
| K861654 | ALBUMIN PROCEDURE | Data Medical Associates, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K861467 | ALBUMIN (BCG) REAGENT | Sigma Diagnostics, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | Sandare Chemical Co., Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K860661 | AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT | Amresco, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K860340 | SERUM ALBUMIN (BCG) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K860213 | ALBUMIN REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K855158 | ALBUMIN REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K854718 | NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 | Nobel Scientific Industries, Inc. | 1985-12-19 | Traditional | PDF ↗ |
| K854181 | IN-VITRO TEST DETERMINATION OF ALBUMIN | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K853978 | TDX AMYLASE | Abbott Laboratories | 1985-10-15 | Traditional | PDF ↗ |
| K853868 | ALBUMIN SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K853049 | ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE | Simmler, Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K850931 | ALBUMIN | Dilab, Inc. | 1985-06-26 | Traditional | PDF ↗ |
| K852007 | ALB BCG REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K851308 | ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S | Technicon Instruments Corp. | 1985-04-17 | Traditional | PDF ↗ |
| K844330 | ALBUMIN REAGENT FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843831 | ALBUMIN REAGENT SET | Livonia Diagnostics, Inc. | 1984-10-11 | Traditional | PDF ↗ |
| K843104 | ALBUMIN ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-07 | Traditional | PDF ↗ |
| K843108 | SYSTEMATE ALBUMIN | Em Diagnostic Systems, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K841063 | ALBUMIN REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840782 | ALBUMIN REAGENT | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K840291 | MCS ALBUMIN REAGENT | Medilab Corp. | 1984-03-30 | Traditional | PDF ↗ |
| K833699 | ALBUMIN REAGENT CS-716 | Fisher Scientific Co., LLC | 1984-01-13 | Traditional | PDF ↗ |
| K832747 | ALBUMIN REAGENT SET | Biorent Diagnostic, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831585 | ALBUMIN REAGENT (BCG | Reagents Applications, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K830536 | FLOW-PAC ALBUMIN REAGENT | Amresco, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823575 | COBAS STANDARDS FOR ALBUMIN | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K823574 | COBAS REAGENT FOR ALBUMIN | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822471 | PSI ALBUMIN REAGENT | Pointe Scientific, Inc., | 1982-09-14 | Traditional | PDF ↗ |
| K821880 | ULTRA CHEM ALB | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821193 | ALBUMIN REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K821225 | ALBUMIN REAGENT | Hi Chem, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K812030 | KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) | Eastman Kodak Company | 1981-08-03 | Traditional | PDF ↗ |
| K811662 | ALBUMIN TEST | King Diagnostics, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K803237 | AMES SERA-PAK ALBUMIN REAGENT KIT | Miles Laboratories, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K802436 | CENTRIFICHEM ALBUMIN | Union Carbide Corp. | 1980-10-31 | Traditional | PDF ↗ |
| K802157 | BCG REAGENT SERUM ALBUMIN W/TECHNICON | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801750 | BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY | Beckman Instruments, Inc. | 1980-09-16 | Traditional | PDF ↗ |
Product code CIX · Class II · Clinical Chemistry. Data: openFDA.