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FDA 510(k) Application Details - K953847
Device Classification Name
Hexokinase, Glucose
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510(K) Number
K953847
Device Name
Hexokinase, Glucose
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG, NJ 08876-3771 US
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Contact
MARIA FEIJOO
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Regulation Number
862.1345
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Classification Product Code
CFR
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More FDA Info for this Product Code
Date Received
08/16/1995
Decision Date
02/13/1996
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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