The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bio-rad D-10 Dual Program.
| Device ID | K041444 |
| 510k Number | K041444 |
| Device Name: | BIO-RAD D-10 DUAL PROGRAM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES 1500 CAPITOL AVENUE MAILSTOP 7602 Sacramento, CA 95814 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-01 |
| Decision Date | 2004-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817003509 | K041444 | 000 |
| 00847817003462 | K041444 | 000 |
| 00847817003455 | K041444 | 000 |
| 00847817003448 | K041444 | 000 |
| 00847817003394 | K041444 | 000 |
| 00847817000096 | K041444 | 000 |