510(k) K070640 ยท MMI Immunoassay Method, Troponin Subunit
ARCHITECT STAT TROPONIN-1; MYOGLOBIN
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Sep 13, 2007 |
| Received | Mar 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070640
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.