VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

Chronic Lymphocytic Leukemia Fish Probe Kit

ABBOTT MOLECULAR, INC.

The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Vysis Cll Fish Probe Kit (vysis Lsi Tp53 Spectrumorange/atm Spectrumgreen) And Lsi D135319 Spectrumorange/13q34.

Pre-market Notification Details

• Device ID: K100015
• 510k Number: K100015
• Device Name: VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
• Classification: Chronic Lymphocytic Leukemia Fish Probe Kit
• Applicant: ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018
• Contact: Pamela L Swatkowski
• Correspondent: Pamela L Swatkowski; ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018
• Product Code: OVQ
• CFR Regulation Number: 866.6040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-04
• Decision Date: 2011-08-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884999007772	K100015	000