Cleared Traditional

VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

K153712 · Radiometer America, Inc. · Chemistry
Jan 2016
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K153712 is an FDA 510(k) clearance for the VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Radiometer America, Inc. (Brea, US). The FDA issued a Cleared decision on January 28, 2016, 35 days after receiving the submission on December 24, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K153712 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2015
Decision Date January 28, 2016
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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