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510(k) K191914

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

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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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)