Name: Predicase
Price: 199 USD

K-number	K230863
Device name	ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Applicant	Zeus Scientific
Product code	LSR
Device class	Class II
Decision date	Jul 13, 2023
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

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