Cleared Traditional

RANDOX PHENYTOIN

K011393 · Randox Laboratories, Ltd. · Toxicology
Dec 2001
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K011393 is an FDA 510(k) clearance for the RANDOX PHENYTOIN, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on December 4, 2001, 211 days after receiving the submission on May 7, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K011393 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2001
Decision Date December 04, 2001
Days to Decision 211 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

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