Cleared Special

FreeStyle InsuLinx Blood Glucose Monotioring System

K152328 · Abott Laboratories · Chemistry
Sep 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K152328 is an FDA 510(k) clearance for the FreeStyle InsuLinx Blood Glucose Monotioring System, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Abott Laboratories (Alameda, US). The FDA issued a Cleared decision on September 17, 2015, 30 days after receiving the submission on August 18, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K152328 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2015
Decision Date September 17, 2015
Days to Decision 30 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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