510(k) K061257 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DBEST HCG PANEL TEST KIT
| Applicant | Ameritek USA, Inc., Everett WA, US |
| Decision | Substantially Equivalent, May 4, 2007 |
| Received | May 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061257
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.