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510(k) K043519

ARIOL HER-2/NEU FISH by Applied Imaging Corp. — Product Code NTH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2005
Date Received
December 20, 2004
Clearance Type
Traditional
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 Applied Imaging Corp.

  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • K033200 — ARIOL (March 18, 2004)
  • K031715 — ARIOL HER-2/NEU IHC (January 8, 2004)
  • K001420 — SLIDESCAN (August 30, 2000)
  • K980375 — WINSCAN AUTOMATED IMAGING SYSTEM (June 9, 1998)
  • K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (August 20, 1990)

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)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)