The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Statstrip Xpress Blood Glucose Monitoring System.
| Device ID | K170464 |
| 510k Number | K170464 |
| Device Name: | StatStrip Xpress Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-15 |
| Decision Date | 2017-11-07 |
| Summary: | summary |