The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Statstrip Glucose Hospital Meter System.
| Device ID | K132121 |
| 510k Number | K132121 |
| Device Name: | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM |
| Classification | Prescription Use Blood Glucose Meter For Near-patient Testing |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Contact | Paul W Macdonald, Phd |
| Correspondent | Paul W Macdonald, Phd NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Product Code | PZI |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2014-09-24 |
| Summary: | summary |