Cleared Traditional

RANDOX GENTAMICIN

K012978 · Randox Laboratories, Ltd. · Toxicology
Sep 2001
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K012978 is an FDA 510(k) clearance for the RANDOX GENTAMICIN, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on September 18, 2001, 74 days after receiving the submission on July 6, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K012978 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2001
Decision Date September 18, 2001
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCD — Enzyme Immunoassay, Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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