K-number	K983151
Device name	IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
Applicant	Beckman Coulter, Inc.
Product code	KXT
Device class	Class II
Decision date	Nov 5, 1998
Decision	Substantially Equivalent
Regulation	862.3320

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IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

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