510(k) K771814 ยท KSF Kit, Quality Control For Blood Banking Reagents
REAGENT CONFIDENCE SERA
| Applicant | Ortho Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 7, 1977 |
| Received | Sep 27, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771814
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.