The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Turbo Hba1c Kit - 2.0.
| Device ID | K142448 |
| 510k Number | K142448 |
| Device Name: | VARIANT II TURBO HbA1c Kit - 2.0 |
| 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 | 2014-09-02 |
| Decision Date | 2015-03-24 |
| Summary: | summary |