The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova One Blood Glucose Monitor.
| Device ID | K122435 |
| 510k Number | K122435 |
| Device Name: | NOVA ONE BLOOD GLUCOSE MONITOR |
| Classification | Glucose Dehydrogenase, Glucose |
| 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 | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2012-12-20 |
| Summary: | summary |