Arkray Factory USA, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3 (2 Class I)
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1850-2019 | Class II | AUTION HYBRID AU-4050 | May 3, 2019 |
| Z-0630-2016 | Class I | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For | December 18, 2015 |
| Z-0631-2016 | Class I | arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. | December 18, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | May 19, 2011 |
| K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | June 9, 2010 |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | November 24, 2009 |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | October 23, 2009 |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | October 9, 2009 |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | August 14, 2009 |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | October 21, 2008 |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | June 13, 2008 |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | August 9, 2007 |