510(k) K972200

Device: ANEUVYSION
Applicant: VYSIS
510(k) number: K972200
Product code: OYU
Decision: Substantially Equivalent (SESE)
Decision date: 1997-10-20
Date received: 1997-06-10
Regulation: 866.4700
Classification name: Dna-probe Kit, Human Chromosome
Medical specialty: Immunology
Review panel: Pathology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RUSSEL K EVANS
Address: 3100 Woodcreek Dr. Downers Grove IL US 60515 60515

FDA Registration Numbers#

3019837962
3005248192

Source Documents#

Other 510(k) Records For Product Code OYU #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K010288	ANEUVYSION MULITICOLOR DNA PROBE KIT	Vysis	2001-04-13
K953591	CEP 8 SPECTRUMORANGE DNA PROBE KIT	Vysis	1996-11-29

Legacy Summary#

summary

FDA Review#

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