K171059 is an FDA 510(k) clearance for the Nova StatSensor Creatinine Hospital Meter System. This device is classified as a Electrode, Ion Based, Enzymatic, Creatinine (Class II - Special Controls, product code CGL).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on May 26, 2017, 46 days after receiving the submission on April 10, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K171059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2017 |
| Decision Date | May 26, 2017 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGL — Electrode, Ion Based, Enzymatic, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |