K170316 is an FDA 510(k) clearance for the ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 19, 2017, 260 days after receiving the submission on February 1, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K170316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2017 |
| Decision Date | October 19, 2017 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |