FDA 510(k) Applications for Medical Device Product Code "DDR"
(Myoglobin, Antigen, Antiserum, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983848 | ABBOTT LABORATORIES | ABBOTT AXSYM MYOGLOBIN | 11/16/1998 |
| K962344 | BAYER CORP. | MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | 08/15/1996 |
| K231832 | Beckman Coulter, Inc | Access Myoglobin | 09/18/2023 |
| K080481 | BECKMAN COULTER, INC. | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | 02/20/2009 |
| K000196 | BECKMAN COULTER, INC. | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | 02/18/2000 |
| K021229 | BECKMAN COULTER, INC. | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 | 06/28/2002 |
| K983176 | BOEHRINGER MANNHEIM CORP. | ELECSYS MYOGLOBIN STAT ASSAY | 09/24/1998 |
| K972513 | BOEHRINGER MANNHEIM CORP. | TINAQUANT MYOGLOBIN ASSAY | 07/28/1997 |
| K974325 | CHIRON DIAGNOSTICS CORP. | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | 12/08/1997 |
| K984191 | DADE BEHRING, INC. | MYOGLOBIN FLEX REAGENT CARTRIDGE | 12/10/1998 |
| K984065 | DADE BEHRING, INC. | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | 12/14/1998 |
| K981102 | DADE BEHRING, INC. | STRATUS CS MYOGLOBIN (MYO) TESTPAK | 04/27/1998 |
| K965213 | DADE INTL., INC. | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY | 02/10/1997 |
| K983970 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 | 11/25/1998 |
| K991796 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | 06/09/1999 |
| K991277 | DIAGNOSTIC PRODUCTS CORP. | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | 04/27/1999 |
| K123785 | DIAZYME LABORATORIES | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | 06/07/2013 |
| K042924 | FISHER DIAGNOSTICS | ARCHITECT STAT MYO IMMUNOASSAY | 01/24/2005 |
| K042982 | INSTRUMENTATION LABORATORY CO. | QUANTEX MYOGLOBIN | 12/22/2004 |
| K992976 | KAMIYA BIOMEDICAL CO. | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | 11/01/1999 |
| K984145 | OLYMPUS DIAGNOSTICA GMBH | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | 12/23/1998 |
| K033300 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS | 11/05/2003 |
| K010700 | RANDOX LABORATORIES, LTD. | RANDOX MYOGLOBIN | 05/08/2001 |
| K012040 | RESPONSE BIOMEDICAL CORP. | RAMP MYOGLOBIN ASSAY | 12/18/2001 |
| K083260 | Roche Diagnostics | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | 10/16/2009 |
| K061683 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | 07/21/2006 |
| K122599 | Siemens Healthcare Diagnostics Inc. | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | 10/03/2012 |
| K982679 | SPECTRAL DIAGNOSTICS, INC. | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | 10/07/1998 |
| K963680 | TEXAS IMMUNOLOGY, INC. | TARGET MYOGLOBIN TEST | 02/06/1997 |
| K981012 | TOSOH MEDICS, INC. | AIA-PACK MYOGLOBIN ASSAY | 05/28/1998 |
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