Name: Predicase
Price: 199 USD

K-number	K132828
Device name	ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
Applicant	Roche Diagnostics
Product code	JKR
Device class	Class II
Decision date	Dec 4, 2013
Decision	Substantially Equivalent
Regulation	862.1140

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3

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