510(k) K041194 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
| Applicant | Medical Analysis Systems, Inc., Camarillo CA, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | May 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041194
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.