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510(k) K103532

AUTOREADER 2 by Trek Diagnostic Systems — Product Code LRG

K103532 is an FDA 510(k) premarket notification submitted by Trek Diagnostic Systems for the device "AUTOREADER 2". The FDA issued a decision of Substantially Equivalent on August 26, 2011. 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. Trek Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2011
Date Received
December 1, 2010
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

Other clearances by Trek Diagnostic Systems

  • K133038 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (January 31, 2014)
  • K112276 — VIZION (November 16, 2011)
  • K111615 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES (November 8, 2011)
  • K110583 — SENSITITRE OPTIREAD (September 22, 2011)
  • K111429 — SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND TH (August 18, 2011)
  • K103456 — THE SENSITITRE AIM (June 22, 2011)
  • K110331 — SENSITITRE AIM (TM) (April 27, 2011)
  • K093741 — SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILI (February 25, 2010)
  • K093865 — SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (February 17, 2010)
  • K092445 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (December 16, 2009)

Other clearances for product code LRG

  • K191914 — Thermo Scientific Sensititre ARIS HiQ System (November 6, 2019)
  • K191918 — Thermo Scientific Sensititre ARIS HiQ System (November 6, 2019)
  • K110583 — SENSITITRE OPTIREAD (September 22, 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