510(k) K012559 ยท JHI Visual, Pregnancy Hcg, Prescription Use
POLY STAT HCG TEST
| Applicant | Bion Diagnostic Sciences, Redmond WA, US |
| Decision | Substantially Equivalent, Oct 16, 2001 |
| Received | Aug 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012559
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.