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510(k) K033982

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST by Vysis — Product Code MMW

K033982 is an FDA 510(k) premarket notification submitted by Vysis for the device "MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST". The FDA issued a decision of Substantially Equivalent on January 22, 2004. The device falls under product code MMW (System, Test, Tumor Marker, Monitoring, Bladder), a Class II device regulated under 21 CFR 866.6010. Vysis has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2004
Date Received
December 23, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Tumor Marker, Monitoring, Bladder
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Vysis

  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)
  • K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT (February 8, 2002)
  • K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (August 3, 2001)
  • K010288 — ANEUVYSION MULITICOLOR DNA PROBE KIT (April 13, 2001)
  • K972200 — ANEUVYSION (October 20, 1997)
  • K954214 — CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT (January 21, 1997)
  • K962873 — CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (January 13, 1997)
  • K953591 — CEP 8 SPECTRUMORANGE DNA PROBE KIT (November 29, 1996)

Other clearances for product code MMW

  • K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX (May 4, 2023)
  • K021231 — NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (July 30, 2002)
  • K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT (February 8, 2002)
  • K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (August 3, 2001)
  • K974845 — BTA STAT TEST PRESCRIPTION HOME USE (December 8, 1998)
  • K971402 — BARD BTA TRAK TEST (April 15, 1998)
  • K970353 — AURA TEK FDP (April 30, 1997)
  • K964151 — BARD AND BTA TEST (April 16, 1997)

FDA data resources