CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

K Number: K962873 · Decision Jan 13, 1997

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Device Name: CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K Number: K962873
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 866.6040
Medical Specialty: Immunology
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Vysis
Date Received: July 23, 1996
Decision Date: January 13, 1997
Product Code: OVQ
Advisory Committee: Immunology
Review Advisory Committee: PA
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
OVQ	Chronic Lymphocytic Leukemia Fish Probe Kit	FDA class 2	Immunology

Other 510(k) clearances with the same product code (OVQ), ordered by most recent decision date.

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K Number	Device Name	Decision Date	Decision
DEN040010	VYSIS AUTOVYSION SYSTEM	Dec 13, 2004	Unknown
K033982	MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST	Jan 22, 2004	Substantially Equivalent
K013785	UROVYSION BLADDER CANCER RECURRENCE KIT	Feb 8, 2002	Substantially Equivalent
K011031	VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT	Aug 3, 2001	Substantially Equivalent
K010288	ANEUVYSION MULITICOLOR DNA PROBE KIT	Apr 13, 2001	Substantially Equivalent
K972200	ANEUVYSION	Oct 20, 1997	Substantially Equivalent
K954214	CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT	Jan 21, 1997	Substantially Equivalent
K953591	CEP 8 SPECTRUMORANGE DNA PROBE KIT	Nov 29, 1996	Substantially Equivalent