The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for D-10 Hemoglobin A1c Program; D-10 Dual Program.
| Device ID | K060001 |
| 510k Number | K060001 |
| Device Name: | D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Jackie Buckley BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-03 |
| Decision Date | 2006-01-20 |
| Summary: | summary |