Name: Predicase
Price: 199 USD

K-number	K102432
Device name	DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
Applicant	Diazyme Laboratories
Product code	MRG
Device class	Class II
Decision date	Jan 14, 2011
Decision	Substantially Equivalent
Regulation	862.1825

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View the full FDA submission: accessdata.fda.gov

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DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,

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