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Clever Check TD-3215/DR. T TD-3216 Blood Glucose and Blood Pressure Measurement Systems

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051936

by Taidoc Technology Corporation

Identifiers

510(k) Number
K051936 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a blood glucose and blood pressure measurement system intended for in vitro diagnostic use. It is designed for the quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites including the palm, forearm, and upper arm.

The system is supplied by Taidoc Technology Corporation and received FDA 510(k) clearance under K051936 with product code NBW. It was determined to be substantially equivalent (SESE) on August 8, 2005, following submission on July 18, 2005, and is classified under the Clinical Chemistry advisory committee.

Frequently asked questions

What is the Clever Check TD-3215/DR. T TD-3216 system used for?

The Clever Check TD-3215/DR. T TD-3216 system is intended for in vitro diagnostic use and is designed for the quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites including the palm, forearm, and upper arm, as well as blood pressure measurement.

How is the Clever Check TD-3215/DR. T TD-3216 system supplied and by whom?

The system is supplied by Taidoc Technology Corporation, the manufacturer, and was cleared through the FDA 510(k) process under submission K051936.

What regulatory pathway was used for the Clever Check TD-3215/DR. T TD-3216 system?

The device received FDA 510(k) clearance under K051936, was determined to be substantially equivalent (SESE) on August 8, 2005, following submission on July 18, 2005, and is classified under the Clinical Chemistry advisory committee.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clever Check Td-3215/Dr. T Td-3216 Blood Glucose and Blood Pressure ..., Clever Chek Td-3213/ Clever Chek Td-3215/ Dr. T Td-3216/ Clever Chek Td ..., Clever Check Td-3215/Dr. T Td-3216 Blood Glucose and Blood Pressure ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K051936 24 fields · synced Oct 6, 2026