Name: Predicase
Price: 199 USD

K-number	K982935
Device name	SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
Applicant	Beckman Coulter, Inc.
Product code	KXT
Device class	Class II
Decision date	Oct 14, 1998
Decision	Substantially Equivalent
Regulation	862.3320

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Source

View the full FDA submission: accessdata.fda.gov

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SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR

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