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FDA 510(k) Application Details - K100525
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K100525
Device Name
Glucose Oxidase, Glucose
Applicant
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL, WA 98021 US
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Contact
Debra Hutson
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
02/24/2010
Decision Date
12/15/2010
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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