Arkray Factory, Inc.

FDA Regulatory Profile

Arkray Factory, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 3 FDA inspections, and 2 compliance actions on record. Its most recent 510(k) clearance was granted on April 10, 2019.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
3
Compliance Actions
2

Recent 510(k) Clearances

K-NumberDeviceDate
K183306GLUCOCARD® W onyx Blood Glucose Monitoring SystemApril 10, 2019
K170064GLUCOCARD W Blood Glucose Monitoring SystemAugust 16, 2017
K162822ADAMS A1c HA-8180V, CALIBRATOR 80June 29, 2017
K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemSeptember 17, 2014
K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMSeptember 5, 2014
K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTJune 30, 2014