The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Assure Platinum And Glucocard Vital Blood Glucose Monitoring Systems.
| Device ID | K091102 |
| 510k Number | K091102 |
| Device Name: | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS |
| 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 | 2009-04-16 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10605388022940 | K091102 | 000 |
| 10605388022933 | K091102 | 000 |
| 10605388022926 | K091102 | 000 |
| 10681131130339 | K091102 | 000 |
| 30015482761999 | K091102 | 000 |
| 30015482761883 | K091102 | 000 |
| 30015482761777 | K091102 | 000 |