OneTouch Ultra Plus Flex Blood Glucose Monitoring System

FDA 510(k) K151611 · Lifescan Europe

Substantially Equivalent

510(k) numberK151611

Submission

Device name
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
Applicant
Lifescan Europe
Zug, CH
Received
June 15, 2015
Decision date
December 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBW – System, Test, Blood Glucose, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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Questions and answers

When was OneTouch Ultra Plus Flex Blood Glucose Monitoring System cleared by the FDA?

OneTouch Ultra Plus Flex Blood Glucose Monitoring System (K151611) received a 510(k) decision of Substantially Equivalent on December 14, 2015, 182 days after the submission was received.

What is the product code of K151611?

The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.