The following data is part of a premarket notification filed by Arkray Factory Inc. with the FDA for Glucocard 01-mini Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System.
| Device ID | K142035 |
| 510k Number | K142035 |
| Device Name: | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ARKRAY FACTORY INC. 5182 WEST 76TH ST Edina, MN 55439 |
| Contact | Lonna M Dendooven |
| Correspondent | Lonna M Dendooven ARKRAY FACTORY INC. 5182 WEST 76TH ST Edina, MN 55439 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-09-05 |
| Summary: | summary |