Telcare, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1270-2025Class IIPhilips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;January 30, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVEJuly 28, 2011