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FDA 510(k) Application Details - K112901
Device Classification Name
Glucose Dehydrogenase, Glucose
More FDA Info for this Device
510(K) Number
K112901
Device Name
Glucose Dehydrogenase, Glucose
Applicant
EPS BIO TECHNOLOGY CORP.
No.8, R&D Rd. III,
Hsinchu Science Park,
HSINCHU CITY 30077 TW
Other 510(k) Applications for this Company
Contact
Cynthia Hung
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
10/03/2011
Decision Date
12/23/2011
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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