K142448 is an FDA 510(k) clearance for the VARIANT II TURBO HbA1c Kit - 2.0. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on March 24, 2015, 203 days after receiving the submission on September 2, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1373. Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes..
| 510(k) Number | K142448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2014 |
| Decision Date | March 24, 2015 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PDJ — Hemoglobin A1c Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1373 |
| Definition | Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes. |