510(k) K140801 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Jun 25, 2014 |
| Received | Mar 31, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140801
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.