510(k) K973957 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DBEST ONE-STEP HCG SERUM/URINE TEST
| Applicant | Ameritek, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Oct 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973957
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.