510(k) K063643 ยท LCP Assay, Glycosylated Hemoglobin
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
| Applicant | Bio-Rad Laboratories Inc., Clinical Systems Divisi, Hercules CA, US |
| Decision | Substantially Equivalent, Dec 27, 2006 |
| Received | Dec 7, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2009 | Bio-Rad Laboratories Inc Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA
Measurement of percent hemoglobin Alc is effective in monitoring Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.