510(k) K083891 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
| Applicant | Maine Standards Co., Windham ME, US |
| Decision | Substantially Equivalent, Mar 23, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083891
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.