510(k) K013119 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
| Applicant | Maine Standards Co., Windham ME, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Sep 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013119
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.