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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
510(k) Number K043519
Device Name ARIOL HER-2/NEU FISH
Applicant
Applied Imaging Corp.
120 Baytech Dr.
San Jose,  CA  95134 -2302
Applicant Contact DIANE C DAY
Correspondent
Applied Imaging Corp.
120 Baytech Dr.
San Jose,  CA  95134 -2302
Correspondent Contact DIANE C DAY
Regulation Number866.4700
Classification Product Code
NTH  
Date Received12/20/2004
Decision Date 04/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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