The following data is part of a premarket notification filed by Arkray Factory Inc. with the FDA for Arkray Glucocard 01 Blood Glucose Monitoring System And Relion Confirm Blood Glucose Monitoring System.
| Device ID | K124021 |
| 510k Number | K124021 |
| Device Name: | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ARKRAY FACTORY INC. 5198 WEST 76TH ST Edina, MN 55439 |
| Contact | Lonna M Dendooven |
| Correspondent | Lonna M Dendooven ARKRAY FACTORY INC. 5198 WEST 76TH ST Edina, MN 55439 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-27 |
| Decision Date | 2014-06-30 |
| Summary: | summary |