Cleared Special

ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM

K122110 · ACON Laboratories, Inc. · Chemistry
Nov 2012
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K122110 is an FDA 510(k) clearance for the ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 2012, 127 days after receiving the submission on July 17, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K122110 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2012
Decision Date November 21, 2012
Days to Decision 127 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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