510(k) K130860 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
| Applicant | Bio-Rad Laboratories, Inc., Clinical Systems Divis, Hercules CA, US |
| Decision | Substantially Equivalent, Apr 25, 2013 |
| Received | Mar 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130860
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.