HardyDisk AST Cefiderocol 30ug (FDC30)

Susceptibility Test Discs, Antimicrobial

Hardy Diagnostics

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Cefiderocol 30ug (fdc30).

Pre-market Notification Details

Device IDK193504
510k NumberK193504
Device Name:HardyDisk AST Cefiderocol 30ug (FDC30)
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant Hardy Diagnostics 1430 West McCoy Lane Santa Maria,  CA  93455
ContactRianna Malherbe
CorrespondentRianna Malherbe
Hardy Diagnostics 1430 West McCoy Lane Santa Maria,  CA  93455
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-18
Decision Date2020-01-23

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