The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips.
| Device ID | K112638 |
| 510k Number | K112638 |
| Device Name: | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2012-03-09 |
| Summary: | summary |