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510(k) K052323

VERSATREK MYCO PZA KIT by Trek Diagnostic Systems, Inc. — Product Code MJA

K052323 is an FDA 510(k) premarket notification submitted by Trek Diagnostic Systems, Inc. for the device "VERSATREK MYCO PZA KIT". The FDA issued a decision of Substantially Equivalent on January 19, 2006. The device falls under product code MJA (Susceptibility Test Powders, Antimycobacterial), a Class II device regulated under 21 CFR 866.1640. Trek Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2006
Date Received
August 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Powders, Antimycobacterial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Trek Diagnostic Systems, Inc.

  • 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)
  • 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)

Other clearances for product code MJA

  • K021582 — BACTEC MGIT 960 PZA KIT (July 13, 2002)
  • K014123 — BACTEC MGIT 960 SIRE KITS (April 19, 2002)
  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (July 13, 1999)

FDA data resources