FDA Product Code
FDA Product Code DDR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5680
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023-09-18 | Traditional | PDF ↗ |
| K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-07 | Traditional | PDF ↗ |
| K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-10-03 | Traditional | PDF ↗ |
| K083260 | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | Roche Diagnostics | 2009-10-16 | Traditional | PDF ↗ |
| K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | Beckman Coulter, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-21 | Traditional | PDF ↗ |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Fisher Diagnostics | 2005-01-24 | Traditional | PDF ↗ |
| K042982 | QUANTEX MYOGLOBIN | Instrumentation Laboratory CO | 2004-12-22 | Traditional | PDF ↗ |
| K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 | Traditional | PDF ↗ |
| K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 | Beckman Coulter, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K012040 | RAMP MYOGLOBIN ASSAY | Response Biomedical Corp. | 2001-12-18 | Traditional | PDF ↗ |
| K010700 | RANDOX MYOGLOBIN | Randox Laboratories, Ltd. | 2001-05-08 | Traditional | PDF ↗ |
| K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | Beckman Coulter, Inc. | 2000-02-18 | Traditional | PDF ↗ |
| K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | Kamiya Biomedical Co. | 1999-11-01 | Traditional | PDF ↗ |
| K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | Diagnostic Products Corp. | 1999-06-09 | Special | PDF ↗ |
| K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | Diagnostic Products Corp. | 1999-04-27 | Special | PDF ↗ |
| K984145 | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | Olympus Diagnostica GmbH | 1998-12-23 | Traditional | PDF ↗ |
| K984065 | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | Dade Behring, Inc. | 1998-12-14 | Traditional | PDF ↗ |
| K984191 | MYOGLOBIN FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1998-12-10 | Traditional | PDF ↗ |
| K983970 | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 | Diagnostic Products Corp. | 1998-11-25 | Traditional | PDF ↗ |
| K983848 | ABBOTT AXSYM MYOGLOBIN | Abbott Laboratories | 1998-11-16 | Traditional | PDF ↗ |
| K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | Spectral Diagnostics, Inc. | 1998-10-07 | Traditional | PDF ↗ |
| K983176 | ELECSYS MYOGLOBIN STAT ASSAY | Boehringer Mannheim Corp. | 1998-09-24 | Traditional | PDF ↗ |
| K981012 | AIA-PACK MYOGLOBIN ASSAY | Tosoh Medics, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K981102 | STRATUS CS MYOGLOBIN (MYO) TESTPAK | Dade Behring, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Chiron Diagnostics Corp. | 1997-12-08 | Traditional | PDF ↗ |
| K972513 | TINAQUANT MYOGLOBIN ASSAY | Boehringer Mannheim Corp. | 1997-07-28 | Traditional | PDF ↗ |
| K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K963680 | TARGET MYOGLOBIN TEST | Texas Immunology, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K962344 | MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-08-15 | Traditional | PDF ↗ |
| K951634 | ACCESS MYOGLOBIN REAGENTS | Bio-Rad Laboratories, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K952360 | CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN | Princeton BioMeditech Corp. | 1995-08-14 | Traditional | PDF ↗ |
| K942052 | LIFESIGN MI MYOGLOBIN | Princeton Biomedix | 1995-02-07 | Traditional | PDF ↗ |
| K923195 | MYOGLOBIN ELISA TEST KIT | Immuno Diagnostic Center, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K922125 | STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1992-07-21 | Traditional | PDF ↗ |
| K922387 | DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL | Baxter Diagnostics, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K915233 | MYOGLOBIN RIA TEST KIT | Pro Diagnostics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K915850 | OPUS MYOGLOBIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K905202 | TURBIQUANT MYOGLOBIN | Behring Diagnostics, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K903687 | TURBIQUANT MYOGLOBIN | Behring Diagnostics, Inc. | 1990-10-16 | Traditional | PDF ↗ |
| K904038 | MYOGLOBIN RIA TEST KIT | Immuno Diagnostic Center, Inc. | 1990-09-24 | Traditional | PDF ↗ |
| K902154 | NA LATEX MYOGLOBIN TEST | Behring Diagnostics, Inc. | 1990-06-01 | Traditional | PDF ↗ |
| K863730 | MYOLEX | Orion Corp. | 1986-10-15 | Traditional | PDF ↗ |
| K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT | Cis Radiopharmaceuticals, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K772095 | HEMAGGLUTINATION INHIBITION TEST | Miles Laboratories, Inc. | 1978-01-05 | Traditional | PDF ↗ |
| K771242 | ANTISERA TO HUMAN FAB FRAGMENT | Kent Laboratories, Inc. | 1977-08-03 | Traditional | PDF ↗ |
Product code DDR · Class II · Immunology. Data: openFDA.