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510(k) K022874

GEN-PROBE APTIMA COMBO 2 ASSAY by Gen-Probe, Inc. — Product Code JTW

K022874 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE APTIMA COMBO 2 ASSAY". The FDA issued a decision of Substantially Equivalent on September 17, 2002. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2002
Date Received
July 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
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 JTW

  • K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (May 25, 2012)
  • K061301 — COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (June 23, 2006)
  • K013819 — URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (February 28, 2002)
  • K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (November 9, 1999)
  • K983244 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (November 30, 1998)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)
  • K904773 — P AND T MEDIUM (December 4, 1990)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)

FDA data resources