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FDA 510(k) Application Details - K043125
Device Classification Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
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510(K) Number
K043125
Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant
ORION DIAGNOSTICA OY
KOIVU MANKKAAN TIE 6
ESPOO 02200 FI
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Contact
ANNIKKA RANTAMA
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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
11/12/2004
Decision Date
05/04/2005
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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