K-number	K842655
Device name	EPSILON DIGOXIN TEST KIT
Applicant	Beckman Instruments, Inc.
Product code	KXT
Device class	Class II
Decision date	Aug 16, 1984
Decision	Substantially Equivalent
Regulation	862.3320

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View the full FDA submission: accessdata.fda.gov

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EPSILON DIGOXIN TEST KIT

Everything you need for a 510(k) submission. Nothing you don't.