510(k) K063400 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Dec 1, 2006 |
| Received | Nov 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2011 | Bio-Rad Laboratories Inc Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Labo Terminated |
LCP | None listed |
| Feb 17, 2011 | Bio-Rad Laboratories Inc Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured Terminated |
LCP | None listed |
| Feb 26, 2010 | Bio-Rad Laboratories Inc Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA.
Intended Use: For the percent determination of hemoglobin A1c in human whole Terminated |
LCP | None listed |
| Mar 24, 2009 | Bio-Rad Laboratories Inc Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA
Provides an integrated method for sample preparation, sepa Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.