510(k) K052101 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 26, 2005 |
| Received | Aug 3, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052101
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.