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FDA 510(k) Application Details - K011113
Device Classification Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
More FDA Info for this Device
510(K) Number
K011113
Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant
SEBIA
13805 WATERLOO
CHELSEA, MI 48118 US
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Contact
BOREK JANIK
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CIN
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More FDA Info for this Product Code
Date Received
04/11/2001
Decision Date
06/13/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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