510(k) K060001 ยท LCP Assay, Glycosylated Hemoglobin
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
| Applicant | Bio-Rad Laboratories, Inc., Hercules CA, US |
| Decision | Substantially Equivalent, Jan 20, 2006 |
| Received | Jan 3, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2016 | Bio-Rad Laboratories, Inc. D-10 Rack Loader;
Model Number 220-0600;
Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent k Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.