510(k) K020662 ยท MMI Immunoassay Method, Troponin Subunit
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 12, 2002 |
| Received | Mar 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020662
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.