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510(k) K070174

AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY by Roche Diagnostics Corporation — Product Code MKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2007
Date Received
January 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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  • K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (May 20, 2014)
  • K110923 — COBAS 4800 CT / NG TEST (January 24, 2012)
  • K091724 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (November 13, 2009)
  • K090824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (June 2, 2009)
  • K081824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (December 11, 2008)
  • K080739 — ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (July 10, 2008)
  • K063451 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (January 22, 2007)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K053287 — COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (August 10, 2006)