K182593 is an FDA 510(k) clearance for the KET-1 Blood Ketone Monitoring System. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).
Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on December 18, 2018, 89 days after receiving the submission on September 20, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K182593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2018 |
| Decision Date | December 18, 2018 |
| Days to Decision | 89 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 |