DDR — Myoglobin, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DDR
- Device Class
- Class II
- Regulation Number
- 866.5680
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231832 | beckman coulter | Access Myoglobin | September 18, 2023 |
| K123785 | diazyme laboratories | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | June 7, 2013 |
| K122599 | siemens healthcare diagnostics | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | October 3, 2012 |
| K083260 | roche diagnostics | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | October 16, 2009 |
| K080481 | beckman coulter | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CA | February 20, 2009 |
| K061683 | roche diagnostics | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | July 21, 2006 |
| K042924 | fisher diagnostics | ARCHITECT STAT MYO IMMUNOASSAY | January 24, 2005 |
| K042982 | instrumentation laboratory | QUANTEX MYOGLOBIN | December 22, 2004 |
| K033300 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI | November 5, 2003 |
| K021229 | beckman coulter | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 | June 28, 2002 |
| K012040 | response biomedical | RAMP MYOGLOBIN ASSAY | December 18, 2001 |
| K010700 | randox laboratories | RANDOX MYOGLOBIN | May 8, 2001 |
| K000196 | beckman coulter | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, | February 18, 2000 |
| K992976 | kamiya biomedical | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | November 1, 1999 |
| K991796 | diagnostic products | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | June 9, 1999 |
| K991277 | diagnostic products | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | April 27, 1999 |
| K984145 | olympus diagnostica | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | December 23, 1998 |
| K984065 | dade behring | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | December 14, 1998 |
| K984191 | dade behring | MYOGLOBIN FLEX REAGENT CARTRIDGE | December 10, 1998 |
| K983970 | diagnostic products | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 | November 25, 1998 |