510(k) K041192 ยท MMI Immunoassay Method, Troponin Subunit
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Aug 12, 2004 |
| Received | May 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2022 | Abbott Laboratories ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 Open, Classified |
MMI | None listed |
| May 10, 2012 | Abbott Laboratories ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratori Terminated |
MMI | None listed |
| Jun 14, 2007 | Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Ab Terminated |
MMI | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.