510(k) K993068 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Oct 4, 1999 |
| Received | Sep 13, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2004 | Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.