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FDA 510(k) Application Details - K171971
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K171971
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
Lite-On Technology Corp. H.S.P.B.
8, Dusing Road, Hsinchu Science Park
Hsinchu City 30078 TW
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Contact
John Lo
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CJE
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More FDA Info for this Product Code
Date Received
06/30/2017
Decision Date
01/25/2018
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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