Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

FDA product code LRG · 45 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.1640
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1987-03-25 – 2019-11-06

LRG 2019-11-06

Thermo Scientific Sensititre ARIS HiQ System

Applicant Thermo Fisher Scientific

K number K191918

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LRG 2019-11-06

Thermo Scientific Sensititre ARIS HiQ System

Applicant Thermo Fisher Scientific

K number K191914

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LRG 2011-09-22

SENSITITRE OPTIREAD

Applicant Trek Diagnostic Systems, Ltd.

K number K110583

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LRG 2011-08-26

AUTOREADER 2

Applicant Trek Diagnostic Systems

K number K103532

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LRG 2011-08-04

MICROSCAN(R) MICROSTREP PLUS(R)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K111677

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LRG 2011-07-20

MICROSCAN (R) MICROSTREP PLUS (R) PANELS

Applicant Siemens Healthcare Diagnostics, Inc.

K number K111205

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LRG 2010-09-10

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

Applicant Siemens Healthcare Diagnostics

K number K101425

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LRG 2008-09-08

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN

Applicant Siemens Healthcare Diagnostics

K number K081013

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LRG 2007-08-20

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN

Applicant Dade Behring, Inc.

K number K071316

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LRG 2006-11-27

MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN

Applicant Dade Behring, Inc.

K number K063299

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LRG 2006-11-09

MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)

Applicant Dade Behring, Inc.

K number K063102

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LRG 2006-11-01

MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML

Applicant Dade Behring, Inc.

K number K063101

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LRG 2006-11-01

MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)

Applicant Dade Behring, Inc.

K number K063099

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LRG 2006-10-27

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)

Applicant Dade Behring, Inc.

K number K063065

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LRG 2006-10-26

MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)

Applicant Dade Behring, Inc.

K number K063064

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LRG 2006-10-26

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)

Applicant Dade Behring, Inc.

K number K063053

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LRG 2006-10-26

MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)

Applicant Dade Behring, Inc.

K number K062375

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LRG 2006-10-13

MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)

Applicant Dade Behring, Inc.

K number K062923

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LRG 2006-10-12

MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)

Applicant Dade Behring, Inc.

K number K062927

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LRG 2006-09-19

MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID

Applicant Dade Behring, Inc.

K number K062596

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LRG 2006-09-19

MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN

Applicant Dade Behring, Inc.

K number K062585

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LRG 2006-09-01

MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)

Applicant Dade Behring, Inc.

K number K062290

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LRG 2006-08-24

MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)

Applicant Dade Behring, Inc.

K number K062293

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LRG 2006-08-23

MICROSCAN MICROSTREP PLUS PANEL

Applicant Dade Behring, Inc.

K number K062276

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LRG 2006-08-23

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)

Applicant Dade Behring, Inc.

K number K062179

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LRG 2006-08-23

MICROSCAN MICROSTREP PLUS PANEL

Applicant Dade Behring, Inc.

K number K061872

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LRG 2006-01-20

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

Applicant Trek Diagnostic Systems, Inc.

K number K053243

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LRG 2005-03-29

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN

Applicant Dade Behring, Inc.

K number K050043

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LRG 2005-03-18

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE

Applicant Dade Behring, Inc.

K number K050585

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LRG 2005-02-17

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)

Applicant Dade Behring, Inc.

K number K043545

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LRG 2004-07-22

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS

Applicant Dade Behring, Inc.

K number K041150

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LRG 2004-03-01

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)

Applicant Dade Behring, Inc.

K number K033948

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LRG 1998-11-18

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

Applicant Dade Microscan, Inc.

K number K981199

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LRG 1994-12-15

ALAMAR ANTIBIOTIC SUSCEPTIBILITY

Applicant Alamar Biosciences Laboratory, Inc.

K number K941425

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LRG 1993-10-22

READAR

Applicant Alamar Biosciences, Inc.

K number K930478

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LRG 1993-10-12

SYNERGY SCREEN TEST, MODIFICATION

Applicant Baxter Healthcare Corp

K number K921977

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LRG 1993-08-31

READAR

Applicant Alamar Biosciences Laboratory, Inc.

K number K925951

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LRG 1993-07-08

READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS

Applicant Alamar Biosciences, Inc.

K number K925859

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LRG 1993-03-12

MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL

Applicant Baxter Diagnostics, Inc.

K number K922482

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LRG 1992-07-01

SENSITITRE ARIS MODULE

Applicant Sensititre , Ltd.

K number K911419

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LRG 1991-11-19

WALKAWAY TM 40

Applicant Baxter Healthcare Corp

K number K911400

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LRG 1990-03-15

AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K900821

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LRG 1990-01-02

AUTOSCEPTOR

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K896447

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LRG 1988-10-27

SCEPTORPETTE SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K883907

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LRG 1987-03-25

ALADIN (TM)

Applicant Analytical Products, Inc.

K number K865062

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