CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment

VYSIS

The following data is part of a premarket notification filed by Vysis with the FDA for Cep X Spectrumorange\y Spectrumgreen Dna Probe Kit.

Pre-market Notification Details

• Device ID: K954214
• 510k Number: K954214
• Device Name: CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
• Classification: Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment
• Applicant: VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515
• Contact: Vicki Anastasi
• Correspondent: Vicki Anastasi; VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515
• Product Code: OXP
• CFR Regulation Number: 866.6010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-07
• Decision Date: 1997-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884999027091	K954214	000
00884999027060	K954214	000
00884999027053	K954214	000
00884999027022	K954214	000