K-number	K171080
Device name	ALP IFCC Gen.2
Applicant	Roche Diagnostics Operations (Rdo)
Product code	CJE
Device class	Class II
Decision date	May 10, 2017
Decision	Substantially Equivalent
Regulation	862.1050

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Source

View the full FDA submission: accessdata.fda.gov

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ALP IFCC Gen.2

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