FDA Product Code
FDA Product Code DFC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5600
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | 2026-06-16 | Traditional | PDF ↗ |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | 2025-01-24 | Traditional | PDF ↗ |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | 2022-12-22 | Traditional | PDF ↗ |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | 2018-03-22 | Traditional | PDF ↗ |
| K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K122722 | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 | Roche Diagnostics | 2012-11-29 | Traditional | PDF ↗ |
| K082488 | DIAZYME LP(A) ASSAY | General Atomics | 2009-01-13 | Traditional | PDF ↗ |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | 2007-09-27 | Traditional | PDF ↗ |
| K050487 | QUANTIA LA(A) | Biokit, S.A. | 2005-04-26 | Traditional | PDF ↗ |
| K023853 | K-ASSAY LP(A) CONTROLS | Kamiya Biomedical Co. | 2002-12-13 | Traditional | PDF ↗ |
| K021660 | K-ASSAY LP(A) ASSAY | Kamiya Biomedical Co. | 2002-07-25 | Traditional | PDF ↗ |
| K013359 | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | 2002-03-08 | Traditional | PDF ↗ |
| K013128 | N LATEX LP(A) | Dade Behring, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013206 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-16 | Traditional | PDF ↗ |
| K013207 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-13 | Traditional | PDF ↗ |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | 2000-07-24 | Special | PDF ↗ |
| K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | 2000-07-24 | Special | PDF ↗ |
| K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | 2000-07-24 | Special | PDF ↗ |
| K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | 2000-07-24 | Special | PDF ↗ |
| K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | 2000-07-23 | Special | PDF ↗ |
| K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | 2000-07-23 | Special | PDF ↗ |
| K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION | Wako Chemicals USA, Inc. | 2000-07-23 | Special | PDF ↗ |
| K000121 | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB | Beckman Coulter, Inc. | 2000-05-17 | Traditional | PDF ↗ |
| K001118 | MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 2000-04-25 | Special | PDF ↗ |
| K994110 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | Diasorin/American Standard Companies | 1999-12-21 | Special | PDF ↗ |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | Trinity Biotech USA | 1999-11-26 | Traditional | PDF ↗ |
| K993669 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 1999-11-17 | Special | PDF ↗ |
| K990595 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B | Roche Diagnostics Corp. | 1999-04-14 | Traditional | PDF ↗ |
| K982708 | SPQ TEST SYSTEM | DiaSorin, Inc. | 1999-04-02 | Traditional | PDF ↗ |
| K981446 | WAKO AUTOKIT LP(A) | Wako Chemicals USA, Inc. | 1999-03-09 | Traditional | PDF ↗ |
| K983281 | APOB | Abbott Laboratories | 1999-01-26 | Traditional | PDF ↗ |
| K980812 | IMX HOMOCYSTEINE | Axis Biochemicals, Asa | 1998-10-01 | Traditional | PDF ↗ |
| K970302 | APO-TEK LP(A) | Perimmune, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K954657 | WAKO AUTOKIT APO B | Wako Chemicals USA, Inc. | 1995-12-20 | Traditional | PDF ↗ |
| K923079 | IL TEST CALIBRATION SET APO A1B | Instrumentation Laboratory CO | 1993-02-05 | Traditional | PDF ↗ |
| K904137 | UC IMU B | Eucardio Laboratory, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K903122 | EQUATE(TM) AQR APO AL/B DUO CONTROL | Binax, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K883711 | QM300 CALIBRATOR F PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K883712 | QM300 CONTROL F PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K872080 | RAICHEM(TM) SPIA(TM) APO B REAGENTS | Reagents Applications, Inc. | 1987-06-15 | Traditional | PDF ↗ |
| K781015 | ANTI-HUMAN LDL SERUM | Icl Scientific | 1978-08-14 | Traditional | PDF ↗ |
| K771912 | LAS-R BETA LIPOPROTEIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-19 | Traditional | PDF ↗ |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | Gelman Instrument Co. | 1977-10-18 | Traditional | PDF ↗ |
Product code DFC · Class II · Immunology. Data: openFDA.