510(k) K032992 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
UNIMARK HOME PREGNANCY TEST DEVICE
| Applicant | Biotech Atlantic, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Nov 21, 2003 |
| Received | Sep 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032992
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.