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510(k) K103456

THE SENSITITRE AIM by Trek Diagnostic Systems — Product Code LIE

K103456 is an FDA 510(k) premarket notification submitted by Trek Diagnostic Systems for the device "THE SENSITITRE AIM". The FDA issued a decision of Substantially Equivalent on June 22, 2011. The device falls under product code LIE (Reagent/Device, Inoculum Calibration), 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
June 22, 2011
Date Received
November 24, 2010
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

  • 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)
  • 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 LIE

  • K221493 — MicroScan Prompt Inoculation System-D (April 5, 2023)
  • K110331 — SENSITITRE AIM (TM) (April 27, 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)

FDA data resources