FDA 510(k) Application Details - K934900

Device Classification Name Hexokinase, Glucose

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510(K) Number K934900
Device Name Hexokinase, Glucose
Applicant HERAEUS KULZER, INC.
P.O. BOX 2004
MISHAWAKA, IN US
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Contact ROSANNE M SAVOL
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Regulation Number 862.1345

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Classification Product Code CFR
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Date Received 10/13/1993
Decision Date 12/07/1993
Decision SE - Substantially Equivalent
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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