Cleared Traditional

RANDOX THEOPHYLLINE

K011771 · Randox Laboratories, Ltd. · Chemistry
Jan 2002
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K011771 is an FDA 510(k) clearance for the RANDOX THEOPHYLLINE, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 17, 2002, 225 days after receiving the submission on June 6, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K011771 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2001
Decision Date January 17, 2002
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KLS — Enzyme Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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