Class Class II

HardyDisk AST Gepotidacin 10µg (GEP10) (K250956)

K250956 2025-06-26 Traditional
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Description

HardyDisk AST Gepotidacin 10µg (GEP10) by Hardy Diagnostics, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250956
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodeJTN
Regulation Number866.1620

Categories

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