The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for D-10 Hemoglobin A1c Program.
| Device ID | K161687 |
| 510k Number | K161687 |
| Device Name: | D-10 Hemoglobin A1c Program |
| Classification | Hemoglobin A1c Test System |
| 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 | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-17 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610521164319 | K161687 | 000 |
| 03610521164302 | K161687 | 000 |
| 03610520530108 | K161687 | 000 |