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510(k) K972200

ANEUVYSION by Vysis — Product Code OYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
June 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Probe Kit, Human Chromosome
Device Class
Class II
Regulation Number
866.4700
Review Panel
PA
Submission Type

Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.

Other clearances by Vysis

  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)
  • 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)
  • 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 OYU

  • K010288 — ANEUVYSION MULITICOLOR DNA PROBE KIT (April 13, 2001)
  • K953591 — CEP 8 SPECTRUMORANGE DNA PROBE KIT (November 29, 1996)