K140654 is an FDA 510(k) clearance for the Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 22, 2015, 434 days after receiving the submission on March 14, 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 | K140654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2014 |
| Decision Date | May 22, 2015 |
| Days to Decision | 434 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. |