Glooko Device System for Glooko Application

FDA 510(k) K132272 · Glooko, Inc.

Substantially Equivalent

510(k) numberK132272

Submission

Device name
Glooko Device System for Glooko Application
Applicant
Glooko, Inc.
Palo Alto, CA, US
Received
July 22, 2013
Decision date
October 17, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 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 Glooko Device System for Glooko Application cleared by the FDA?

Glooko Device System for Glooko Application (K132272) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 87 days after the submission was received.

What is the product code of K132272?

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.