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FDA 510(k) Application Details - K072142
Device Classification Name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K072142
Device Name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
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Contact
DAVID SLAVIN
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CKF
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More FDA Info for this Product Code
Date Received
08/02/2007
Decision Date
06/26/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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