510(k) K894941 ยท JHI Visual, Pregnancy Hcg, Prescription Use
COAT-A-COUNT (TM) HCG IRMA
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 25, 1989 |
| Received | Aug 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894941
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.