Cleared Traditional

K012978 - RANDOX GENTAMICIN (FDA 510(k) Clearance)

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

K012978 is an FDA 510(k) clearance for the RANDOX GENTAMICIN. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K012978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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