K-number	K940569
Device name	DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
Applicant	Sigma Diagnostics, Inc.
Product code	KXT
Device class	Class II
Decision date	Jul 13, 1994
Decision	Substantially Equivalent
Regulation	862.3320

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View the full FDA submission: accessdata.fda.gov

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DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET

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