510(k) K801098 ยท GOL Antigen, Ha (Including Ha Control), Rubella
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
| Applicant | Flow Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 16, 1980 |
| Received | May 9, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801098
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.