510(k) K974512 ยท DHA System, Test, Human Chorionic Gonadotropin
AIMSTICK PBD COMBO PREGNANCY
| Applicant | Germaine Laboratories, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Dec 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974512
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.