ARIOL HER-2/NEU FISH

System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays

APPLIED IMAGING CORP.

The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Ariol Her-2/neu Fish.

Pre-market Notification Details

Device IDK043519
510k NumberK043519
Device Name:ARIOL HER-2/NEU FISH
ClassificationSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Applicant APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose,  CA  95134 -2302
ContactDiane C Day
CorrespondentDiane C Day
APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose,  CA  95134 -2302
Product CodeNTH  
CFR Regulation Number866.4700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-20
Decision Date2005-04-25

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