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510(k) K111409

APTIMA COMBO 2 ASSAY by Gen-Probe, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2012
Date Received
May 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances by Gen-Probe, Inc.

  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • K063664 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (January 25, 2007)
  • K063451 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (January 22, 2007)
  • K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (November 7, 2006)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K061509 — TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (October 4, 2006)
  • K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (August 17, 2006)
  • K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (July 25, 2006)
  • K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY (August 9, 2005)
  • K043144 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (March 14, 2005)

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  • K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (May 20, 2014)
  • K140354 — ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (May 9, 2014)
  • K140887 — COBAS CT/NG V2.0 TEST (May 5, 2014)
  • K132270 — COBAS CT/NG V2.0 TEST (December 2, 2013)
  • K132251 — APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (October 17, 2013)