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510(k) K093741

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES by Trek Diagnostic Systems, Ltd. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2010
Date Received
December 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Trek Diagnostic Systems, Ltd.

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  • 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)
  • K110331 — SENSITITRE AIM (TM) (April 27, 2011)
  • K093865 — SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (February 17, 2010)
  • K092445 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (December 16, 2009)

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