Cleared Traditional

RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

K121588 · Randox Laboratories, Ltd. · Chemistry

Jun 2012

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K121588 is an FDA 510(k) clearance for the RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C 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 June 20, 2012, 20 days after receiving the submission on May 31, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K121588 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2012
Decision Date	June 20, 2012
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF