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FDA 510(k) Application Details - K051447
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K051447
Device Name
Catalytic Methods, Amylase
Applicant
SENTINEL CH. SRL
5 VIA PRINCIPE EUGENIO
MILANO 20155 IT
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Contact
DAVIDE SPADA
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Regulation Number
862.1070
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Classification Product Code
JFJ
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Date Received
06/02/2005
Decision Date
01/26/2006
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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