510(k) K053247 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
| Applicant | Maine Standards Co., Windham ME, US |
| Decision | Substantially Equivalent, Jan 13, 2006 |
| Received | Nov 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053247
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.