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FDA 510(k) Application Details - K030192
Device Classification Name
Device, Automated Cell-Locating
More FDA Info for this Device
510(K) Number
K030192
Device Name
Device, Automated Cell-Locating
Applicant
BIOVIEW LTD.
117 AHUZAH ST.
RA'ANANNA 76703 IL
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Contact
ORLY MAOR
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Regulation Number
864.5260
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Classification Product Code
JOY
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More FDA Info for this Product Code
Date Received
01/21/2003
Decision Date
08/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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