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510(k) DEN040010

VYSIS AUTOVYSION SYSTEM by Vysis — Product Code NTH

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

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  • 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

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  • 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)