510(k) K800239 ยท KSF Kit, Quality Control For Blood Banking Reagents
RH-HR NEGATIVE CONTROL REAGENT
| Applicant | Gotham Biologics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 21, 1980 |
| Received | Feb 5, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800239
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.