The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Max Uric Acid Monitoring System.
| Device ID | K160990 |
| 510k Number | K160990 |
| Device Name: | Nova Max Uric Acid Monitoring System |
| Classification | Uric Acid Test System For At Home Prescription Use |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 PROSPECT STREET Waltham, MA 02454 |
| Contact | Eliza Wang |
| Correspondent | Eliza Wang NOVA BIOMEDICAL CORPORATION 200 PROSPECT STREET Waltham, MA 02454 |
| Product Code | PTC |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2017-04-11 |
| Summary: | summary |