510(k) K040872 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II HEMOGLOBIN A1C
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Apr 15, 2004 |
| Received | Apr 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040872
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Hemoglobin A1c Program Buffer B,
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange h 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.