510(k) K021624 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Jul 12, 2002 |
| Received | May 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021624
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.