510(k) K980736 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
| Applicant | Acon Laboratories Co., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 16, 1998 |
| Received | Feb 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980736
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.