510(k) K974075 ยท MMI Immunoassay Method, Troponin Subunit
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 10, 1997 |
| Received | Oct 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974075
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.