The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Glucocard 01-mini Blood Glucose Monitoring System, Model 73110.
| Device ID | K082417 |
| 510k Number | K082417 |
| Device Name: | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Tom Speikers |
| Correspondent | Tom Speikers 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-10-21 |
| Summary: | summary |