510(k) K050100 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Feb 25, 2005 |
| Received | Jan 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050100
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.