510(k) K042227 ยท MMI Immunoassay Method, Troponin Subunit
INSTANT-VIEW TROPONIN I TEST
| Applicant | Alfa Scientific Designs, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Aug 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042227
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.