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FDA 510(k) Application Details - K041427
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K041427
Device Name
Glucose Oxidase, Glucose
Applicant
ARKRAY, INC.
510 FURNACE DOCK RD.
CORTLANDT MANOR, NY 10567 US
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Contact
HELEN LANDICHO
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
05/28/2004
Decision Date
11/24/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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