510(k) K012430 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Aug 27, 2001 |
| Received | Jul 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012430
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.