Cleared Traditional

RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

K121746 · Randox Laboratories, Ltd. · Chemistry

Jul 2012

Decision

27d

Days

Class 1

Risk

About This 510(k) Submission

K121746 is an FDA 510(k) clearance for the RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID), 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 11, 2012, 27 days after receiving the submission on June 14, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K121746 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2012
Decision Date	July 11, 2012
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF