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510(k) K191914

Thermo Scientific Sensititre ARIS HiQ System by Thermo Fisher Scientific — Product Code LRG

K191914 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Thermo Scientific Sensititre ARIS HiQ System". The FDA issued a decision of Substantially Equivalent on November 6, 2019. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2019
Date Received
July 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxa (April 15, 2025)
  • K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra (February 27, 2025)
  • K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (February 10, 2025)
  • K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (February 10, 2025)

Other clearances for product code LRG

  • K191918 — Thermo Scientific Sensititre ARIS HiQ System (November 6, 2019)
  • K110583 — SENSITITRE OPTIREAD (September 22, 2011)
  • K103532 — AUTOREADER 2 (August 26, 2011)
  • K111677 — MICROSCAN(R) MICROSTREP PLUS(R) (August 4, 2011)
  • K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS (July 20, 2011)
  • K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (September 10, 2010)
  • K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN (September 8, 2008)
  • K071316 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPT (August 20, 2007)
  • K063299 — MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (November 27, 2006)
  • K063102 — MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (November 9, 2006)

FDA data resources