The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Assure Platinum Blood Glucose Monitoring System.
| Device ID | K092104 |
| 510k Number | K092104 |
| Device Name: | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Hamid Idrissi |
| Correspondent | Hamid Idrissi ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | CGA |
| 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 | 2009-07-14 |
| Decision Date | 2009-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30015482501779 | K092104 | 000 |