Arkray Factory USA, Inc.
Arkray Factory USA, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2011, with 3 FDA device recalls on record.
Top product codes for Arkray Factory USA, Inc.
FDA recalls by Arkray Factory USA, Inc.
- Z-1850-2019 — AUTION HYBRID AU-4050
- Z-0630-2016 — arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
- Z-0631-2016 — arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Arkray Factory USA, Inc.
- K110709 — ARK CARE DIABETES MANAGMENT SYSTEM
- K093819 — ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
- K092104 — ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
- K091102 — ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
- K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
- K090332 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
- K082417 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
- K073416 — ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
- K063771 — GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.