510(k) K983674 ยท JMM Column Chromatography & Color Development, Hydroxyproline
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Oct 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983674
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.