510(k) K965048 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 27, 1997 |
| Received | Dec 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965048
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.