Name: Predicase
Price: 199 USD

K-number	K191240
Device name	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
Applicant	Zeus Scientific, Inc.
Product code	LSR
Device class	Class II
Decision date	Jul 29, 2019
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System

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