K171975

Substantially Equivalent

HardyDisk AST Delafloxacin 5 µg (DLX5)

Applicant: Hardy Diagnostics
Product code: JTN
Advisory panel: Microbiology
Date received: 2017-06-30
Decision date: 2017-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.