The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Statstrip Xpress 2 Glucose Hospital Meter System.
| Device ID | K152986 |
| 510k Number | K152986 |
| Device Name: | StatStrip Xpress 2 Glucose Hospital Meter System |
| Classification | Prescription Use Blood Glucose Meter For Near-patient Testing |
| 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 | PZI |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480565100 | K152986 | 000 |