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Visgeneer, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2501-2025Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancOctober 4, 2023
Z-2500-2025Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancOctober 4, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K122181EBCHEK BLOOD GLUCOSE MONITORING SYSTEMAugust 15, 2013
K091765EBCARRYON BLOOD GLUCOSE MONITORING SYSTEMJanuary 19, 2010
K062555EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-GDecember 27, 2006