510(k) K893577 ยท DHA System, Test, Human Chorionic Gonadotropin
STATUS HCG FLUOROMETRIC ENZYME
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Aug 3, 1989 |
| Received | May 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893577
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.