K140801 is an FDA 510(k) clearance for the VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on June 25, 2014, 86 days after receiving the submission on March 31, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K140801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2014 |
| Decision Date | June 25, 2014 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |