Home / 510(k) Clearances / K922906

510(k) K922906

AMPLICOR CHLAMYDIA TRACHOMATIS TEST by Roche Molecular Systems, Inc. — Product Code MKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
June 17, 1992
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

Other clearances by Roche Molecular Systems, Inc.

  • K243753 — cobas liat Bordetella panel nucleic acid test (November 20, 2025)
  • K252481 — cobas CMV (November 3, 2025)
  • K252484 — cobas HCV (November 3, 2025)
  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K243863 — Opulus™ Lymphoma Precision (May 30, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test (April 11, 2025)
  • K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (February 11, 2025)
  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)

Other clearances for product code MKZ

  • K230451 — Aptima® Chlamydia trachomatis Assay (November 16, 2023)
  • 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)
  • K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCE (April 16, 2007)
  • 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)