510(k) K013857 ยท DHA System, Test, Human Chorionic Gonadotropin
AIMSTEP PREGNANCY
| Applicant | Germaine Laboratories, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Jan 22, 2002 |
| Received | Nov 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013857
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.