510(k) K954065 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
| Applicant | Biochem Immunosystems (U.S.), Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | Aug 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954065
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.