K202612

Substantially Equivalent

Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)

Applicant: Thermo Fisher Scientific
Product code: JWY
Advisory panel: Microbiology
Date received: 2020-09-09
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

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