LFW · Class II · 21 CFR 862.3900

FDA Product Code LFW: Fluorescence Polarization Immunoassay, Tobramycin

Leading manufacturers include Roche Diagnostic Systems, Inc., Abbott Laboratories and Sigma Diagnostics, Inc..

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 Feb 01, 1985
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
K843828
Roche Diagnostic Systems, Inc.
Toxicology · 126d

About Product Code LFW - Regulatory Context