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

FDA 510(k) Cleared Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Devices (Product Code LRG)

45 devices
1–24 of 45
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191914
Thermo Fisher Scientific
Microbiology · 112d
Cleared Nov 06, 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918
Thermo Fisher Scientific
Microbiology · 111d
Cleared Aug 04, 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677
Siemens Healthcare Diagnostics, Inc.
Microbiology · 50d
Cleared Jul 20, 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205
Siemens Healthcare Diagnostics, Inc.
Microbiology · 82d
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
K081013
Siemens Healthcare Diagnostics
Microbiology · 152d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
K071316
Dade Behring, Inc.
Microbiology · 102d
Cleared Nov 27, 2006
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299
Dade Behring, Inc.
Microbiology · 26d
Cleared Nov 09, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
K063102
Dade Behring, Inc.
Microbiology · 30d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
K063099
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
K063101
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 27, 2006
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
K063065
Dade Behring, Inc.
Microbiology · 21d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
K062375
Dade Behring, Inc.
Microbiology · 72d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
K063053
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
K063064
Dade Behring, Inc.
Microbiology · 20d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
K062923
Dade Behring, Inc.
Microbiology · 15d
Cleared Oct 12, 2006
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
K062927
Dade Behring, Inc.
Microbiology · 14d
Cleared Sep 19, 2006
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 19, 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 01, 2006
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
K062290
Dade Behring, Inc.
Microbiology · 25d
Cleared Aug 24, 2006
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
K062293
Dade Behring, Inc.
Microbiology · 17d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K061872
Dade Behring, Inc.
Microbiology · 51d
Cleared Aug 23, 2006
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)
K062179
Dade Behring, Inc.
Microbiology · 23d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K062276
Dade Behring, Inc.
Microbiology · 16d

About Product Code LRG - Regulatory Context