The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System.
| Device ID | K131013 |
| 510k Number | K131013 |
| Device Name: | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | 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 | 2013-04-11 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917188062 | K131013 | 000 |
| 00021292005726 | K131013 | 000 |
| 00021292005719 | K131013 | 000 |
| 00021292005702 | K131013 | 000 |