The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Arkray Glucocard 01 Blood Monitoring System.
| Device ID | K073416 |
| 510k Number | K073416 |
| Device Name: | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-06-13 |
| Summary: | summary |