Name: Predicase
Price: 199 USD

K-number	K202574
Device name	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
Applicant	DiaSorin, Inc.
Product code	LSR
Device class	Class II
Decision date	Feb 18, 2021
Decision	Substantially Equivalent
Regulation	866.3830

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

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