510(k) K090699 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Jul 27, 2009 |
| Received | Mar 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090699
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.