510(k) K070819 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
| Applicant | Bio-Rad Laboratories Inc., Clinical Systems Divisi, Hercules CA, US |
| Decision | Substantially Equivalent, Jun 25, 2007 |
| Received | Mar 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Bio-Rad Laboratories, Inc. VARIANT II Link Hemoglobin A1c Program Reorder Pack,
1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood.
Contents:
Elution Buffer A , 1 x 2500 mL
Elution Buffer B, 1 x 2100 Terminated |
KRZ | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-e Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests.
For the determination of Hemoglobin A1c in human whole blood.
Contents:
1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buff Terminated |
LCP | None listed |
| Sep 6, 2011 | Bio-Rad Laboratories, Inc. VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack.
Calibrator/Diluent Set.
IVD.
Kit components:
Elution Buffer A, 2 x 2500 mL
Elution Buffer B, 1 x 2100 mL
Wash/Diluent Solution, 1 x 2500 mL
C Terminated |
LCP | None listed |
| Feb 15, 2011 | Bio-Rad Laboratories Inc Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Cali Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.