K-number	K170901
Device name	ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
Applicant	Biosystems S.A.
Product code	CIX
Device class	Class II
Decision date	Apr 13, 2018
Decision	Substantially Equivalent
Regulation	862.1035

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View the full FDA submission: accessdata.fda.gov

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ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

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