510(k) K963934 ยท MMI Immunoassay Method, Troponin Subunit
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 16, 1996 |
| Received | Oct 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963934
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.