ANEUVYSION

Dna-probe Kit, Human Chromosome

VYSIS

The following data is part of a premarket notification filed by Vysis with the FDA for Aneuvysion.

Pre-market Notification Details

• Device ID: K972200
• 510k Number: K972200
• Device Name: ANEUVYSION
• Classification: Dna-probe Kit, Human Chromosome
• Applicant: VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515
• Contact: Russel K Evans
• Correspondent: Russel K Evans; VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515
• Product Code: OYU
• CFR Regulation Number: 866.4700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-10
• Decision Date: 1997-10-20
• Summary: summary