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FDA 510(k) Application Details - K050236
Device Classification Name
Analyzer, Chromosome, Automated
More FDA Info for this Device
510(K) Number
K050236
Device Name
Analyzer, Chromosome, Automated
Applicant
APPLIED SPECTRAL IMAGING, LTD.
6 SIRENI ST.
HAIFA 32972 IL
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Contact
DAN LAOR
Other 510(k) Applications for this Contact
Regulation Number
864.5260
More FDA Info for this Regulation Number
Classification Product Code
LNJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2005
Decision Date
06/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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