K171537 is an FDA 510(k) clearance for the CAPI 3 Hb A1c. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on September 12, 2017, 110 days after receiving the submission on May 25, 2017.
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 | K171537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2017 |
| Decision Date | September 12, 2017 |
| Days to Decision | 110 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. |