Name: Predicase
Price: 199 USD

K-number	K112624
Device name	ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
Applicant	Roche Diagnostics
Product code	OIU
Device class	Class II
Decision date	Sep 10, 2012
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

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