510(k) K001215 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DBEST HCG 2 IU/ML TEST KIT
| Applicant | Ameritek, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Jun 22, 2000 |
| Received | Apr 14, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K001215
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.