Home / 510(k) Clearances / DEN040010

510(k) DEN040010

VYSIS AUTOVYSION SYSTEM by Vysis — Product Code NTH

DEN040010 is an FDA 510(k) premarket notification submitted by Vysis for the device "VYSIS AUTOVYSION SYSTEM". The FDA issued a decision of De Novo Granted on December 13, 2004. The device falls under product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays), a Class II device regulated under 21 CFR 866.4700. Vysis has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 13, 2004
Date Received
October 13, 2004
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Device Class
Class II
Regulation Number
866.4700
Review Panel
PA
Submission Type

Other clearances by Vysis

  • K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (January 22, 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 NTH

  • K130775 — DUET SYSTEM (May 9, 2014)
  • K122554 — GENASIS SCANVIEW SYSTEM (February 7, 2013)
  • K110345 — SCANVIEW SYSTEM (October 19, 2011)
  • K101291 — SCANVIEW HER2/NEU FISH SYSTEM (November 23, 2010)
  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)

FDA data resources