510(k) K955353 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
| Applicant | Tcpi, Inc., Pompano Beach FL, US |
| Decision | Substantially Equivalent, Mar 19, 1996 |
| Received | Nov 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955353
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.