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FDA 510(k) Application Details - K112272
Device Classification Name
Glucose Dehydrogenase, Glucose
More FDA Info for this Device
510(K) Number
K112272
Device Name
Glucose Dehydrogenase, 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
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
LFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2011
Decision Date
09/07/2011
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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