K160990 is an FDA 510(k) clearance for the Nova Max Uric Acid Monitoring System. This device is classified as a Uric Acid Test System For At Home Prescription Use (Class I - General Controls, product code PTC).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on April 11, 2017, 368 days after receiving the submission on April 8, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1775. For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only..
| 510(k) Number | K160990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2016 |
| Decision Date | April 11, 2017 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PTC — Uric Acid Test System For At Home Prescription Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1775 |
| Definition | For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only. |