510(k) K122472 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
| Applicant | Bio-Rad Laboratories, Inc., Clinical Systems Divis, Hercules CA, US |
| Decision | Substantially Equivalent, Oct 26, 2012 |
| Received | Aug 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122472
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.