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510(k) K920378

PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS by Gen-Probe, Inc. — Product Code LSK

K920378 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS". The FDA issued a decision of Substantially Equivalent on April 29, 1992. The device falls under product code LSK (Dna-Reagents, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1992
Date Received
January 29, 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

Other clearances by Gen-Probe, Inc.

  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • K111409 — APTIMA COMBO 2 ASSAY (May 3, 2012)
  • 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)

Other clearances for product code LSK

  • K092704 — ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8 (May 28, 2010)
  • K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (September 25, 2001)
  • 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)
  • K920302 — PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (April 6, 1994)
  • K874878 — GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (December 29, 1987)
  • K871878 — RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (October 28, 1987)

FDA data resources