Cleared Traditional

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2

K043267 · Randox Laboratories, Ltd. · Chemistry

Feb 2005

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K043267 is an FDA 510(k) clearance for the POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 10, 2005, 76 days after receiving the submission on November 26, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number	K043267 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2004
Decision Date	February 10, 2005
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement