The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Statsensor Creatinine Hospital Meter System.
| Device ID | K171059 |
| 510k Number | K171059 |
| Device Name: | Nova StatSensor Creatinine Hospital Meter System |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| Applicant | Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 |
| Contact | Paul W. Macdonald |
| Correspondent | Paul W. Macdonald Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 |
| Product Code | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2017-05-26 |
| Summary: | summary |