510(k) K031043 ยท LCP Assay, Glycosylated Hemoglobin
D-10 HEMOGLOBIN A1C
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Aug 27, 2003 |
| Received | Apr 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2014 | Bio-Rad Laboratories, Inc. D-10" Hemoglobin Testing System,
Model number: 220-0220
Manufactured by:
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive
Hercules, CA 94545
The D-10 Hemoglobin Testing System is a single module Terminated |
LCP | None listed |
| Feb 10, 2014 | Bio-Rad Laboratories, Inc. D-10 Dual Program, which contains Update Kit D-10 A1c program diskette.
United States; Bio-Rad Laboratories,
Hercules, CA 94547
The Bio-Rad D-10 Hemoglobin Testing System provides an integrated meth Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Program Reorder Pack; 400 tests;
For the determination of Hemoglobin A1c in human whole blood. IVD
Contents:
1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer
2. Elution Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Supplemental Reagent Pack:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid c Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. D-10 Hemoglobin A1c Program Elution Buffer 2:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid ch Terminated |
LCP | None listed |
| Apr 13, 2011 | Bio-Rad Laboratories, Inc., Hercules, CA Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette;
Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufa Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.