510(k) K041728 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Aug 11, 2004 |
| Received | Jun 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041728
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.