510(k) K070452 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, May 7, 2007 |
| Received | Feb 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2010 | Bio-Rad Laboratories Inc Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.