Cleared Traditional

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

K043268 · Randox Laboratories, Ltd. · Chemistry

Feb 2005

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K043268 is an FDA 510(k) clearance for the SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2, a Uranyl Acetate/zinc Acetate, Sodium (Class II — Special Controls, product code CEI), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 15, 2005, 81 days after receiving the submission on November 26, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K043268 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2004
Decision Date	February 15, 2005
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement