Telcare, LLC
FDA Regulatory Profile
Telcare, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1270-2025, Class II) was initiated on January 30, 2025. Its most recent 510(k) clearance was granted on July 28, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1270-2025 | Class II | Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; | January 30, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110571 | TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE | July 28, 2011 |