Cleared Traditional

RANDOX CARBAMAZEPINE

K011648 · Randox Laboratories, Ltd. · Toxicology
Jan 2002
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K011648 is an FDA 510(k) clearance for the RANDOX CARBAMAZEPINE, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 15, 2002, 231 days after receiving the submission on May 29, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K011648 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2001
Decision Date January 15, 2002
Days to Decision 231 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KLT — Enzyme Immunoassay, Carbamazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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