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FDA 510(k) Application Details - K073634
Device Classification Name
Enzymatic Method, Creatinine
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510(K) Number
K073634
Device Name
Enzymatic Method, Creatinine
Applicant
SENTINEL CH. SpA
Via Robert Koch, 2
Milano 20152 IT
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Contact
FABIO ROTA
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Regulation Number
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
12/26/2007
Decision Date
06/19/2008
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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