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510(k) K920302

PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY by Gen-Probe, Inc. — Product Code LSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1994
Date Received
January 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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  • 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)
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  • 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)

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  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K920378 — PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (April 29, 1992)
  • K874878 — GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (December 29, 1987)
  • K871878 — RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (October 28, 1987)