The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Turbo Link Hemoglobin A1c Program/testing System.
| Device ID | K140801 |
| 510k Number | K140801 |
| Device Name: | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Ebony Mckinnies |
| Correspondent | Ebony Mckinnies 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 | 2014-03-31 |
| Decision Date | 2014-06-25 |
| Summary: | summary |