510(k) K060632 ยท NBC Test, Natriuretic Peptide
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 6, 2006 |
| Received | Mar 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2018 | ORTHO-CLINICAL DIAGNOSTICS VITROS NT-proBNP Reagent, Cat No. 6802156
Product Usage:
For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and Open, Classified |
NBC | None listed |
| Mar 7, 2017 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.