Product code DDR
- Device name
- Myoglobin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5680
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | 2023-09-18 |
| K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-07 |
| K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-10-03 |
| K083260 | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | Roche Diagnostics | 2009-10-16 |
| K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | Beckman Coulter, Inc. | 2009-02-20 |
| K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | 2006-07-21 |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Fisher Diagnostics | 2005-01-24 |
| K042982 | QUANTEX MYOGLOBIN | Instrumentation Laboratory CO | 2004-12-22 |
| K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 |
| K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 | Beckman Coulter, Inc. | 2002-06-28 |
| K012040 | RAMP MYOGLOBIN ASSAY | Response Biomedical Corp. | 2001-12-18 |
| K010700 | RANDOX MYOGLOBIN | Randox Laboratories, Ltd. | 2001-05-08 |
| K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | Beckman Coulter, Inc. | 2000-02-18 |
| K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | Kamiya Biomedical Co. | 1999-11-01 |
| K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | Diagnostic Products Corp. | 1999-06-09 |
| K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | Diagnostic Products Corp. | 1999-04-27 |
| K984145 | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | Olympus Diagnostica GmbH | 1998-12-23 |
| K984065 | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | Dade Behring, Inc. | 1998-12-14 |
| K984191 | MYOGLOBIN FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1998-12-10 |
| K983970 | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 | Diagnostic Products Corp. | 1998-11-25 |
| K983848 | ABBOTT AXSYM MYOGLOBIN | Abbott Laboratories | 1998-11-16 |
| K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | Spectral Diagnostics, Inc. | 1998-10-07 |
| K983176 | ELECSYS MYOGLOBIN STAT ASSAY | Boehringer Mannheim Corp. | 1998-09-24 |
| K981012 | AIA-PACK MYOGLOBIN ASSAY | Tosoh Medics, Inc. | 1998-05-28 |
| K981102 | STRATUS CS MYOGLOBIN (MYO) TESTPAK | Dade Behring, Inc. | 1998-04-27 |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | Chiron Diagnostics Corp. | 1997-12-08 |
| K972513 | TINAQUANT MYOGLOBIN ASSAY | Boehringer Mannheim Corp. | 1997-07-28 |
| K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | 1997-02-10 |
| K963680 | TARGET MYOGLOBIN TEST | Texas Immunology, Inc. | 1997-02-06 |
| K962344 | MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-08-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00895160002496 | Fluoro-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | 2019-05-24 |
| 30014613337157 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337164 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337911 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 04015630940059 | Elecsys Myoglobin | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630939541 | CalSet Myoglobin | Roche Diagnostics GmbH | 2017-04-17 |
| 00817089020634 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020627 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020610 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00899722002740 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00842768004544 | Stratus® CS Acute Care™ cTNI DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004612 | Stratus® CS Acute Care™ Myoglobin CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004629 | Stratus® CS Acute Care™ MYO DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004506 | Stratus® CS Acute Care™ CKMB CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004520 | Stratus® CS Acute Care™ cTNI TestPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004513 | Stratus® CS Acute Care™ CKMB DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004537 | Stratus® CS Acute Care™ cTNI CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630921270 | Myoglobin Gen2 Tinaquant Myoglobin Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630939060 | Elecsys Myoglobin Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630911707 | Elecsys Myoglobin STAT CalSet | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630939077 | Elecsys Myoglobin STAT Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928644 | Tinaquant Myoglobin Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921294 | Tinaquant Myoglobin Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630914449 | Elecsys Myoglobin CalSet | Roche Diagnostics GmbH | 2016-09-20 |
| 00895160002137 | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002090 | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002083 | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 10627966005022 | RAMP® Myoglobin TEST KIT; 25 TESTS | Response Biomedical Corp | 2016-09-05 |
| 00380740003302 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |
| 00380740003272 | ARCHITECT | Abbott Ireland Diagnostics | 2016-06-06 |