K-number	K033873
Device name	ELECSYS C-PEPTIDE CALSET
Applicant	Roche Diagnostics Corp.
Product code	JIX
Device class	Class II
Decision date	Feb 13, 2004
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS C-PEPTIDE CALSET

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