Name: Predicase
Price: 199 USD

K-number	K040095
Device name	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
Applicant	Immco Diagnostics, Inc.
Product code	MVM
Device class	Class II
Decision date	Mar 5, 2004
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

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