510(k) K973825 ยท DHA System, Test, Human Chorionic Gonadotropin
MIDSTREAM HOME REGNANCY TEST
| Applicant | Germaine Laboratories, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Dec 19, 1997 |
| Received | Oct 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973825
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.