Panels › Immunology › Product code DDR · Class 2
Myoglobin, Antigen, Antiserum, Control
Regulation 866.5680
0510(k)s in 12 months (46 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DDR
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 4 | 1 |
| Dade Behring, Inc. | 3 | 2 |
| Abbott Laboratories | 1 | 3 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 3 |
| Behring Diagnostics, Inc. | 3 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Baxter Diagnostics, Inc. | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Immuno Diagnostic Center, Inc. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2023 | K231832 | Access Myoglobin Beckman Coulter, Inc. | DDR |
| Jun 7, 2013 | K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET Diazyme Laboratories | DDR |
| Oct 3, 2012 | K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR Siemens Healthcare Diagnostics, Inc. | DDR |
| Oct 16, 2009 | K083260 | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN Roche Diagnostics | DDR |
| Feb 20, 2009 | K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS Beckman Coulter, Inc. | DDR |
| Jul 21, 2006 | K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM Roche Diagnostics Corp. | DDR |
| Jan 24, 2005 | K042924 | ARCHITECT STAT MYO IMMUNOASSAY Fisher Diagnostics | DDR |
| Dec 22, 2004 | K042982 | QUANTEX MYOGLOBIN Instrumentation Laboratory CO | DDR |
| Nov 5, 2003 | K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | DDR |
| Jun 28, 2002 | K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 Beckman Coulter, Inc. | DDR |
| Dec 18, 2001 | K012040 | RAMP MYOGLOBIN ASSAY Response Biomedical Corp., CA | DDR |
| May 8, 2001 | K010700 | RANDOX MYOGLOBIN Randox Laboratories, Ltd., IE | DDR |
| Feb 18, 2000 | K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 Beckman Coulter, Inc. | DDR |
| Nov 1, 1999 | K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR Kamiya Biomedical Co. | DDR |
| Jun 9, 1999 | K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 Diagnostic Products Corp. | DDR |
| Apr 27, 1999 | K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 Diagnostic Products Corp. | DDR |
| Dec 23, 1998 | K984145 | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT Olympus Diagnostica GmbH | DDR |
| Dec 14, 1998 | K984065 | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK Dade Behring, Inc. | DDR |
| Dec 10, 1998 | K984191 | MYOGLOBIN FLEX REAGENT CARTRIDGE Dade Behring, Inc. | DDR |
| Nov 25, 1998 | K983970 | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 Diagnostic Products Corp. | DDR |
| Nov 16, 1998 | K983848 | ABBOTT AXSYM MYOGLOBIN Abbott Laboratories | DDR |
| Oct 7, 1998 | K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST Spectral Diagnostics, Inc., CA | DDR |
| Sep 24, 1998 | K983176 | ELECSYS MYOGLOBIN STAT ASSAY Boehringer Mannheim Corp. | DDR |
| May 28, 1998 | K981012 | AIA-PACK MYOGLOBIN ASSAY Tosoh Medics, Inc. | DDR |
| Apr 27, 1998 | K981102 | STRATUS CS MYOGLOBIN (MYO) TESTPAK Dade Behring, Inc. | DDR |
| Dec 8, 1997 | K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN Chiron Diagnostics Corp. | DDR |
| Jul 28, 1997 | K972513 | TINAQUANT MYOGLOBIN ASSAY Boehringer Mannheim Corp. | DDR |
| Feb 10, 1997 | K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. | DDR |
| Feb 6, 1997 | K963680 | TARGET MYOGLOBIN TEST Texas Immunology, Inc. | DDR |
| Aug 15, 1996 | K962344 | MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | DDR |
| Sep 27, 1995 | K951634 | ACCESS MYOGLOBIN REAGENTS Bio-Rad Laboratories, Inc. | DDR |
| Aug 14, 1995 | K952360 | CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN Princeton BioMeditech Corp. | DDR |
| Feb 7, 1995 | K942052 | LIFESIGN MI MYOGLOBIN Princeton Biomedix | DDR |
| Nov 6, 1992 | K923195 | MYOGLOBIN ELISA TEST KIT Immuno Diagnostic Center, Inc. | DDR |
| Jul 21, 1992 | K922125 | STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. | DDR |
| Jul 15, 1992 | K922387 | DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL Baxter Diagnostics, Inc. | DDR |
| Mar 30, 1992 | K915233 | MYOGLOBIN RIA TEST KIT Pro Diagnostics, Inc. | DDR |
| Mar 17, 1992 | K915850 | OPUS MYOGLOBIN TEST SYSTEM Pb Diagnostic Systems, Inc. | DDR |
| Dec 13, 1990 | K905202 | TURBIQUANT MYOGLOBIN Behring Diagnostics, Inc. | DDR |
| Oct 16, 1990 | K903687 | TURBIQUANT MYOGLOBIN Behring Diagnostics, Inc. | DDR |
| Sep 24, 1990 | K904038 | MYOGLOBIN RIA TEST KIT Immuno Diagnostic Center, Inc. | DDR |
| Jun 1, 1990 | K902154 | NA LATEX MYOGLOBIN TEST Behring Diagnostics, Inc. | DDR |
| Oct 15, 1986 | K863730 | MYOLEX Orion Corp., FI | DDR |
| Jun 22, 1978 | K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT Cis Radiopharmaceuticals, Inc. | DDR |
| Jan 5, 1978 | K772095 | HEMAGGLUTINATION INHIBITION TEST Miles Laboratories, Inc. | DDR |
| Aug 3, 1977 | K771242 | ANTISERA TO HUMAN FAB FRAGMENT Kent Laboratories, Inc. | DDR |
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