Name: Predicase
Price: 199 USD

K-number	K182474
Device name	alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
Applicant	Biosystems S.A.
Product code	JFJ
Device class	Class II
Decision date	May 2, 2019
Decision	Substantially Equivalent
Regulation	862.1070

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Source

View the full FDA submission: accessdata.fda.gov

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alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

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