Panels › Clinical Chemistry › Product code MMI · Class 2
Immunoassay Method, Troponin Subunit
Regulation 862.1215
1510(k)s in 12 months (95 all time)
0recalls in 12 months (56 all time)
54recalls that name a 510(k)
Top companies in MMI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2006 | Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | K041192 |
| Feb 9, 2006 | Roche Diagnostics Corp. Roche brand Elecsys Troponin T; catalog number 2017644. Terminated |
MMI | K040733 K051752 +1 |
| Jul 20, 2004 | Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Orth Terminated |
MMI | K031031 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | K974103 |
| May 29, 2003 | Roche Diagnostics Corp. Elecsys Troponin T STAT; catalog number 2017423 Terminated |
MMI | K984104 |
| May 29, 2003 | Roche Diagnostics Corp. Elecsys Troponin T; catalog number 2017644 Terminated |
MMI | K984105 |
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