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FDA 510(k) Application Details - K122554
Device Classification Name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
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510(K) Number
K122554
Device Name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Applicant
APPLIED SPECTRAL IMAGING, LTD.
A-109 NETO- GOLF
CAESAREA 30889 IL
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Contact
ILAN SHARON
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Regulation Number
866.4700
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Classification Product Code
NTH
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More FDA Info for this Product Code
Date Received
08/21/2012
Decision Date
02/07/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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