510(k) K012122 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
| Applicant | Maine Standards Co., Windham ME, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012122
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.