510(k) K913236 ยท DHA System, Test, Human Chorionic Gonadotropin
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jul 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913236
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.