Atlas FDA

LRG

45 FDA 510(k) clearances · Product code

60 daysmedian time to decision
268 days90th percentile
45clearances measured

FDA profile

Official device name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 11 · 2010: 12 · 2011: 11 · 2012: 8 · 2014: 31 · 2015: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Thermo Scientific Sensititre ARIS HiQ System (K191918)Thermo Fisher Scientific2019-11-06
Thermo Scientific Sensititre ARIS HiQ System (K191914)Thermo Fisher Scientific2019-11-06
SENSITITRE OPTIREAD (K110583)Trek Diagnostic Systems, Ltd.2011-09-22
AUTOREADER 2 (K103532)Trek Diagnostic Systems2011-08-26
MICROSCAN(R) MICROSTREP PLUS(R) (K111677)Siemens Healthcare Diagnostics, Inc.2011-08-04
MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205)Siemens Healthcare Diagnostics, Inc.2011-07-20
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425)Siemens Healthcare Diagnostics2010-09-10
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013)Siemens Healthcare Diagnostics2008-09-08
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN (K071316)Dade Behring, Inc.2007-08-20
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (K063299)Dade Behring, Inc.2006-11-27
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102)Dade Behring, Inc.2006-11-09
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) (K063099)Dade Behring, Inc.2006-11-01
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML (K063101)Dade Behring, Inc.2006-11-01
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) (K063065)Dade Behring, Inc.2006-10-27
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) (K063053)Dade Behring, Inc.2006-10-26
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) (K063064)Dade Behring, Inc.2006-10-26
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) (K062375)Dade Behring, Inc.2006-10-26
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) (K062923)Dade Behring, Inc.2006-10-13
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) (K062927)Dade Behring, Inc.2006-10-12
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN (K062585)Dade Behring, Inc.2006-09-19
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID (K062596)Dade Behring, Inc.2006-09-19
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) (K062290)Dade Behring, Inc.2006-09-01
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) (K062293)Dade Behring, Inc.2006-08-24
MICROSCAN MICROSTREP PLUS PANEL (K061872)Dade Behring, Inc.2006-08-23
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) (K062179)Dade Behring, Inc.2006-08-23
MICROSCAN MICROSTREP PLUS PANEL (K062276)Dade Behring, Inc.2006-08-23
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K053243)Trek Diagnostic Systems, Inc.2006-01-20
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (K050043)Dade Behring, Inc.2005-03-29
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE (K050585)Dade Behring, Inc.2005-03-18
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) (K043545)Dade Behring, Inc.2005-02-17
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS (K041150)Dade Behring, Inc.2004-07-22
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) (K033948)Dade Behring, Inc.2004-03-01
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN (K981199)Dade Microscan, Inc.1998-11-18
ALAMAR ANTIBIOTIC SUSCEPTIBILITY (K941425)Alamar Biosciences Laboratory, Inc.1994-12-15
READAR (K930478)Alamar Biosciences, Inc.1993-10-22
SYNERGY SCREEN TEST, MODIFICATION (K921977)Baxter Healthcare Corp1993-10-12
READAR (K925951)Alamar Biosciences Laboratory, Inc.1993-08-31
READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS (K925859)Alamar Biosciences, Inc.1993-07-08
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL (K922482)Baxter Diagnostics, Inc.1993-03-12
SENSITITRE ARIS MODULE (K911419)Sensititre , Ltd.1992-07-01
WALKAWAY TM 40 (K911400)Baxter Healthcare Corp1991-11-19
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING (K900821)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-15
AUTOSCEPTOR (K896447)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-01-02
SCEPTORPETTE SYSTEM (K883907)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-27
ALADIN (TM) (K865062)Analytical Products, Inc.1987-03-25

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