The following data is part of a premarket notification filed by Arkray Factory Usa, Inc. with the FDA for Assure Pro Blood Glucose Monitoring System, Model 46001.
Device ID | K090332 |
510k Number | K090332 |
Device Name: | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
Contact | Hamid Idrissi |
Correspondent | Hamid Idrissi ARKRAY Factory USA, Inc. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
Product Code | NBW |
Subsequent Product Code | CGA |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-10 |
Decision Date | 2009-08-14 |
Summary: | summary |