Cleared Traditional

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR

K900707 · Innotron of Oregon, Inc. · Toxicology
Apr 1990
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K900707 is an FDA 510(k) clearance for the MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR, a Fluorescence Polarization Immunoassay, Tobramycin (Class II — Special Controls, product code LFW), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on April 20, 1990, 67 days after receiving the submission on February 12, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K900707 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1990
Decision Date April 20, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LFW — Fluorescence Polarization Immunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

Similar Devices — LFW Fluorescence Polarization Immunoassay, Tobramycin

All 9
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670 · Roche Diagnostic Systems, Inc. · Feb 1997
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371 · Sigma Diagnostics, Inc. · Nov 1994
AXSYM TOBRAMYCIN
K941614 · Abbott Laboratories · Aug 1994
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · Microgenics Corp. · Jul 1991
FPR TOBRAMYCIN KIT
K894531 · Colony Laboratories, Inc. · Sep 1989
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · Innotron of Oregon, Inc. · Aug 1987