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FDA 510(k) Application Details - K062892
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K062892
Device Name
Glucose Oxidase, Glucose
Applicant
EUMED BIOTECHNOLOGY CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN CHU CITY 300 TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
09/26/2006
Decision Date
01/22/2007
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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