LFW · Class II · 21 CFR 862.3900

FDA Product Code LFW: Fluorescence Polarization Immunoassay, Tobramycin

Leading manufacturers include Roche Diagnostic Systems, Inc., Innotron of Oregon, Inc. and Microgenics Corp..

10
Total
10
Cleared
70d
Avg days
1984
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Tobramycin Devices (Product Code LFW)

10 devices
1–10 of 10
Cleared Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670
Roche Diagnostic Systems, Inc.
Toxicology · 75d
Cleared Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371
Sigma Diagnostics, Inc.
Chemistry · 64d
Cleared Aug 18, 1994
AXSYM TOBRAMYCIN
K941614
Abbott Laboratories
Toxicology · 136d
Cleared Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
K912143
Microgenics Corp.
Toxicology · 72d
Cleared Apr 20, 1990
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Aug 17, 1987
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562
Innotron of Oregon, Inc.
Chemistry · 54d
Cleared Feb 01, 1985
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
K843828
Roche Diagnostic Systems, Inc.
Toxicology · 126d

About Product Code LFW - Regulatory Context