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FDA 510(k) Application Details - K111728
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K111728
Device Name
Glucose Oxidase, Glucose
Applicant
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY, HSINCHU 30077 TW
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Contact
YC LEI
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Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
06/20/2011
Decision Date
09/16/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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