K-number	K854503
Device name	AST(OPTIMIZED) REAGENT
Applicant	Sigma Diagnostics, Inc.
Product code	CIT
Device class	Class II
Decision date	Nov 25, 1985
Decision	Substantially Equivalent
Regulation	862.1100

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View the full FDA submission: accessdata.fda.gov

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AST(OPTIMIZED) REAGENT

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