Name: Predicase
Price: 199 USD

K-number	K162788
Device name	ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
Applicant	Immco Diagnostics, Inc.
Product code	MSV
Device class	Class II
Decision date	Jun 19, 2017
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

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