K192326

Substantially Equivalent

HardyDisk AST Lefamulin 20µg (LMU20)

Applicant: Hardy Diagnostics
Product code: JTN
Advisory panel: Microbiology
Date received: 2019-08-27
Decision date: 2019-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

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