Cleared Traditional

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

K131776 · Randox Laboratories, Ltd. · Chemistry
Jul 2013
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K131776 is an FDA 510(k) clearance for the ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on July 18, 2013, 31 days after receiving the submission on June 17, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131776 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2013
Decision Date July 18, 2013
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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