510(k) K991067 ยท JHI Visual, Pregnancy Hcg, Prescription Use
MODIFICATION OF: DAVIDSTRIP HCG
| Applicant | Simex Medical, Inc., Tukwila WA, US |
| Decision | Substantially Equivalent, Apr 27, 1999 |
| Received | Mar 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991067
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.