Cleared Traditional

RANDOX PHENOBARBITAL

K011303 · Randox Laboratories, Ltd. · Toxicology
Jul 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K011303 is an FDA 510(k) clearance for the RANDOX PHENOBARBITAL, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on July 2, 2001, 63 days after receiving the submission on April 30, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K011303 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2001
Decision Date July 02, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DLZ — Enzyme Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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