LRG · Class II · 21 CFR 866.1640

FDA Product Code LRG: Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Leading manufacturers include Dade Behring, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Thermo Fisher Scientific.

45
Total
45
Cleared
111d
Avg days
1987
Since
45 devices
25–45 of 45
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948
Dade Behring, Inc.
Microbiology · 73d
Cleared Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
K921977
Baxter Healthcare Corp
Microbiology · 539d
Cleared Nov 19, 1991
WALKAWAY TM 40
K911400
Baxter Healthcare Corp
Microbiology · 235d
Cleared Mar 15, 1990
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 22d
Cleared Jan 02, 1990
AUTOSCEPTOR
K896447
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 54d
Cleared Oct 27, 1988
SCEPTORPETTE SYSTEM
K883907
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 42d