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FDA 510(k) Application Details - K182474
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K182474
Device Name
Catalytic Methods, Amylase
Applicant
BioSystems S.A.
Costa Brava, 30
Barcelona 08030 ES
Other 510(k) Applications for this Company
Contact
Noelia Gil
Other 510(k) Applications for this Contact
Regulation Number
862.1070
More FDA Info for this Regulation Number
Classification Product Code
JFJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2018
Decision Date
05/02/2019
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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