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FDA 510(k) Application Details - K962415
Device Classification Name
Glucose Dehydrogenase, Glucose
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510(K) Number
K962415
Device Name
Glucose Dehydrogenase, Glucose
Applicant
HEMOCUE, INC.
23263 MADERO, SUITE A
MISSION VIEJO, CA 92691 US
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Contact
CLAS RUNNBERG
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Regulation Number
862.1345
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Classification Product Code
LFR
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More FDA Info for this Product Code
Date Received
06/12/1996
Decision Date
10/15/1996
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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