510(k) K934516 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ADVANCE PREGNANCY TEST MODIFICATION
| Applicant | Ortho Pharmaceutical Corp., Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 24, 1994 |
| Received | Sep 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934516
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.