K170463 is an FDA 510(k) clearance for the KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).
Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on April 13, 2018, 422 days after receiving the submission on February 15, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K170463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2017 |
| Decision Date | April 13, 2018 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1435 |