510(k) K922073 ยท DHA System, Test, Human Chorionic Gonadotropin
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Oct 19, 1992 |
| Received | May 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922073
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.