Name: Predicase
Price: 199 USD

K-number	K163177
Device name	ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
Applicant	Immco Diagnostics, Inc.
Product code	MST
Device class	Class II
Decision date	Jul 28, 2017
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

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