510(k) K972721 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Aug 6, 1997 |
| Received | Jul 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972721
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.