Cleared Traditional

K092602 - FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
(FDA 510(k) Clearance)

K092602 · Abbott Diabetes Care, Inc. · Chemistry

May 2010

Decision

262d

Days

Class 2

Risk

K092602 is an FDA 510(k) clearance for the FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on May 14, 2010, 262 days after receiving the submission on August 25, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K092602 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2009
Decision Date	May 14, 2010
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF