510(k) K981165 ยท JHI Visual, Pregnancy Hcg, Prescription Use
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
| Applicant | Germaine Laboratories, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Apr 16, 1998 |
| Received | Mar 31, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981165
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.