The following data is part of a premarket notification filed by Chdiagnostics Llc with the FDA for Senova(r) Blood Glucose Monitor.
| Device ID | K032076 |
| 510k Number | K032076 |
| Device Name: | SENOVA(R) BLOOD GLUCOSE MONITOR |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | CHDIAGNOSTICS LLC 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | Richard N Phillips |
| Correspondent | Richard N Phillips CHDIAGNOSTICS LLC 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-09-30 |