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510(k) K110331

SENSITITRE AIM (TM) by Trek Diagnostic Systems, Ltd. — Product Code LIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2011
Date Received
February 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent/Device, Inoculum Calibration
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Trek Diagnostic Systems, Ltd.

  • 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)
  • K103532 — AUTOREADER 2 (August 26, 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)
  • 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 LIE

  • K221493 — MicroScan Prompt Inoculation System-D (April 5, 2023)
  • K103456 — THE SENSITITRE AIM (June 22, 2011)
  • K935566 — SENSI-CAL AMCO AEPA-1 (March 29, 1994)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K890339 — DIFCO DIRECTOR INOCULATION SYSTEM (February 7, 1989)
  • K820299 — PROMPT INOCULATION SYSTEM (March 15, 1982)