510(k) K041444 ยท LCP Assay, Glycosylated Hemoglobin
BIO-RAD D-10 DUAL PROGRAM
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Jun 9, 2004 |
| Received | Jun 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2011 | Bio-Rad Laboratories Inc D-10 Dual Program Reorder Pack;
contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2.
Bio-Rad Laboratories Inc. Hercules, CA.
Product Usage:
Short Prog Terminated |
LCP | None listed |
| Jan 25, 2007 | Bio-Rad Laboratories Inc Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.