K-number	K970931
Device name	COPALIS TORC TOTAL ANTIBODY ASSAY
Applicant	Sienna Biotech, Inc.
Product code	LQN
Device class	Class II
Decision date	Apr 24, 1997
Decision	Substantially Equivalent
Regulation	866.3510

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View the full FDA submission: accessdata.fda.gov

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COPALIS TORC TOTAL ANTIBODY ASSAY

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