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 Siemens Healthcare Diagnostics.

45
Total
45
Cleared
111d
Avg days
1987
Since
45 devices
25–45 of 45
Cleared Jan 20, 2006
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Mar 29, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
K050043
Dade Behring, Inc.
Microbiology · 78d
Cleared Mar 18, 2005
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
K050585
Dade Behring, Inc.
Microbiology · 11d
Cleared Feb 17, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
K043545
Dade Behring, Inc.
Microbiology · 56d
Cleared Jul 22, 2004
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
K041150
Dade Behring, Inc.
Microbiology · 80d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948
Dade Behring, Inc.
Microbiology · 73d
Cleared Nov 18, 1998
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
K981199
Dade Microscan, Inc.
Microbiology · 230d
Cleared Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
K921977
Baxter Healthcare Corp
Microbiology · 539d
Cleared Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482
Baxter Diagnostics, Inc.
Microbiology · 289d
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
Cleared Mar 25, 1987
ALADIN (TM)
K865062
Analytical Products, Inc.
Microbiology · 91d