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FDA 510(k) Application Details - K071671
Device Classification Name
Automated Digital Image Manual Interpretation Microscope
More FDA Info for this Device
510(K) Number
K071671
Device Name
Automated Digital Image Manual Interpretation Microscope
Applicant
APERIO TECHNOLOGIES
1430 VANTAGE COURT, SUITE 106
VISTA, CA 92081 US
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Contact
PERRY JOHNSTON
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Regulation Number
864.1860
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Classification Product Code
OEO
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More FDA Info for this Product Code
Date Received
06/19/2007
Decision Date
12/28/2007
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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