510(k) K013194 ยท JHI Visual, Pregnancy Hcg, Prescription Use
UNIMARK HCG COMBO PREGNANCY TEST
| Applicant | Biotech Atlantic, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2001 |
| Received | Sep 25, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013194
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.