Name: Predicase
Price: 199 USD

K-number	K203292
Device name	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Applicant	Gold Standard Diagnostics
Product code	LSR
Device class	Class II
Decision date	Mar 22, 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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Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

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