The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for D-100 Hba1c, D-100 Hba1c Calibrator Pack.
| Device ID | K151321 |
| 510k Number | K151321 |
| Device Name: | D-100 HbA1c, D-100 HbA1c Calibrator Pack |
| 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 |
| Subsequent Product Code | JIT |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817025693 | K151321 | 000 |
| 00847817025679 | K151321 | 000 |
| 00847817020155 | K151321 | 000 |
| 00847817016035 | K151321 | 000 |
| 00847817016028 | K151321 | 000 |
| 00847817016004 | K151321 | 000 |
| 00847817015991 | K151321 | 000 |
| 00847817015953 | K151321 | 000 |