K-number	K052982
Device name	ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
Applicant	Roche Diagnostics
Product code	JIT
Device class	Class II
Decision date	Oct 28, 2005
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

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