Cleared Traditional

FPR GENTAMICIN KIT

K894523 · Colony Laboratories, Inc. · Toxicology
Sep 1989
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K894523 is an FDA 510(k) clearance for the FPR GENTAMICIN KIT, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989, 70 days after receiving the submission on July 20, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K894523 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date September 28, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

Similar Devices — LCQ Fluorescent Immunoassay Gentamicin

All 18
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad · Aug 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · Oxis Intl., Inc. · Feb 1996
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · Sigma Diagnostics, Inc. · Nov 1994
OPUS GENTAMICIN
K905721 · Pb Diagnostic Systems, Inc. · Feb 1991
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990