510(k) K042643 ยท DCF Albumin, Antigen, Antiserum, Control
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Sep 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used t Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.