510(k) K200023— Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Substantially Equivalent

Gold Standard Diagnostics

Clearance details

Applicant: Gold Standard Diagnostics
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2020-01-06
Decision date: 2020-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

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