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FDA 510(k) Application Details - K061431
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K061431
Device Name
Glucose Oxidase, Glucose
Applicant
US DIAGNOSTICS, INC.
304 PARK AVENUE SOUTH
SUITE 218
NEW YORK, NY 10010-4301 US
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Contact
EDWARD LETKO
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
05/24/2006
Decision Date
01/12/2007
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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