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510(k) K013785

UROVYSION BLADDER CANCER RECURRENCE KIT by Vysis — Product Code MMW

K013785 is an FDA 510(k) premarket notification submitted by Vysis for the device "UROVYSION BLADDER CANCER RECURRENCE KIT". The FDA issued a decision of Substantially Equivalent on February 8, 2002. 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
February 8, 2002
Date Received
November 14, 2001
Clearance Type
Abbreviated
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)
  • K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (January 22, 2004)
  • 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)
  • K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (January 22, 2004)
  • K021231 — NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (July 30, 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