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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K182474
Device Name alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
Applicant
Biosystems S.A.
Costa Brava, 30
Barcelona,  ES 08030
Applicant Contact Noelia Gil
Correspondent
Biosystems S.A.
Costa Brava, 30
Barcelona,  ES 08030
Correspondent Contact Noelia Gil
Regulation Number862.1070
Classification Product Code
JFJ  
Subsequent Product Code
CIG  
Date Received09/10/2018
Decision Date 05/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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