Name: Predicase
Price: 199 USD

K-number	K193051
Device name	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
Applicant	DiaSorin, Inc.
Product code	LSR
Device class	Class II
Decision date	Jan 29, 2020
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

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