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 IDK100015
510k NumberK100015
Device Name:VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
ClassificationChronic Lymphocytic Leukemia Fish Probe Kit
Applicant ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines,  IL  60018
ContactPamela L Swatkowski
CorrespondentPamela L Swatkowski
ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines,  IL  60018
Product CodeOVQ  
CFR Regulation Number866.6040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-04
Decision Date2011-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884999007772 K100015 000

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