K201551 is an FDA 510(k) clearance for the KetoSens BT 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 September 9, 2020, 92 days after receiving the submission on June 9, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K201551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2020 |
| Decision Date | September 09, 2020 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1435 |