FDA.reportPublic FDA data

Telcare, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085143953008514395Telcare, LLC1Y2026-01-01600 West Ridge Road, Suite 200 Linwood PA US 19061
30085143953008514395Telcare, LLC1N2020-04-25150 Baker Avenue Ext Ste 300 Concord MA US 01742

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859519002018BioTel Care® Test Strips - Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution.877-777-4710support@telcare.com
00859519002056BioTel Care® Double Control Solution - Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.877-777-4710support@telcare.com
00859519002223BioTel Care® Blood Glucose Monitoring System - The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter.877-777-4710support@telcare.com
00859519002247Telserve® Data Management System - The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.877-777-4710support@telcare.com
00859519002261BioTel Care® Test Strips - Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution.877-777-4710support@telcare.com
10859519002053BioTel Care® Double Control Solution - Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.877-777-4710support@telcare.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3220251654209664K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USENBW2011-07-28
1379542064429554K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USENBW2011-07-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW22011-07-28

PMN#

GUDID#

BioTel Care® Blood Glucose Monitoring System - The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter.

TELCARE, LLC

2019-03-11