510(k) K023544 ยท JHI Visual, Pregnancy Hcg, Prescription Use
GENZYME CONTRAST II HCG URINE/SERUM TEST
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jan 16, 2003 |
| Received | Oct 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023544
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.