Onetouch Verio (TM) Iq Blood Glucose Monitoring System

FDA 510(k) K110637 · Cilag GmbH International

Substantially Equivalent

510(k) numberK110637

Submission

Device name
Onetouch Verio (TM) Iq Blood Glucose Monitoring System
Applicant
Cilag GmbH International
Zug, CH
Received
March 4, 2011
Decision date
September 7, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFR – Glucose Dehydrogenase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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More from Taidoc Technology Corporation

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K131363Onetouch Verio Blood Glucose Monitoring SystemNBW · Traditional 08/30/2013SE
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Questions and answers

When was Onetouch Verio (TM) Iq Blood Glucose Monitoring System cleared by the FDA?

Onetouch Verio (TM) Iq Blood Glucose Monitoring System (K110637) received a 510(k) decision of Substantially Equivalent on September 7, 2011, 187 days after the submission was received.

What is the product code of K110637?

The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.