The following data is part of a premarket notification filed by Arkray Factory Inc. with the FDA for Glucocard 01 Blood Glocose Monitoring System/relion Confirm Blood Glucose Monitoring System.
| Device ID | K142336 |
| 510k Number | K142336 |
| Device Name: | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ARKRAY FACTORY INC. 1480 KOJI KONAN-CHO Koka-shi, JP 520-3306 |
| Contact | Kazuya Yorimitsu |
| Correspondent | Lonna M Dendooven ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. Edina, MN 55439 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2014-09-17 |
| Summary: | summary |