FDA 510(k) Applications Submitted by ARKRAY Factory USA, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090332 |
02/10/2009 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 |
ARKRAY Factory USA, Inc. |
| K090653 |
03/11/2009 |
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
| K091102 |
04/16/2009 |
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS |
ARKRAY Factory USA, Inc. |
| K092104 |
07/14/2009 |
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
| K082417 |
08/22/2008 |
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 |
ARKRAY Factory USA, Inc. |
| K073416 |
12/03/2007 |
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
| K093819 |
12/14/2009 |
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) |
ARKRAY Factory USA, Inc. |
| K063771 |
12/21/2006 |
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
| K110709 |
03/14/2011 |
ARK CARE DIABETES MANAGMENT SYSTEM |
ARKRAY Factory USA, Inc. |
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