DDR — Myoglobin, Antigen, Antiserum, Control Class II
FDA product code DDR covers "Myoglobin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5680. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |