K-number	K941085
Device name	LIPASE-PS ASSAY PROCEDURE NO. 805
Applicant	Sigma Diagnostics, Inc.
Product code	CHI
Device class	Class I
Decision date	May 17, 1994
Decision	Substantially Equivalent
Regulation	862.1465

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View the full FDA submission: accessdata.fda.gov

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LIPASE-PS ASSAY PROCEDURE NO. 805

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