The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Max Blood Glucose Monitor System, 90001,90002.
| Device ID | K070255 |
| 510k Number | K070255 |
| Device Name: | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald, Phd |
| Correspondent | Paul W Macdonald, Phd NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2007-06-13 |