510(k) K964155 ยท JHI Visual, Pregnancy Hcg, Prescription Use
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
| Applicant | Genzyme Diagnostics, San Carlos CA, US |
| Decision | Substantially Equivalent, Nov 25, 1996 |
| Received | Oct 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964155
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.