K-number	K123563
Device name	LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
Applicant	Magellan Diagnostics
Product code	DOF
Device class	Class II
Decision date	Aug 20, 2013
Decision	Substantially Equivalent
Regulation	862.3550

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Source

View the full FDA submission: accessdata.fda.gov

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LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM

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