Name: Predicase
Price: 199 USD

K-number	DEN140001
Device name	ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
Applicant	Kronus Market Development Associates, Inc.
Product code	PHF
Device class	Class II
Decision date	Aug 20, 2014
Decision	Not Substantially Equivalent
Regulation	866.5670

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Source

View the full FDA submission: accessdata.fda.gov

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ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

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