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Found 1 results

510(k) Data Aggregation

K Number

Device Name

HardyDisk AST Cefiderocol 30ug (FDC30)

Manufacturer

Hardy Diagnostics

Date Cleared

2020-01-23

(36 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

HardyDisk AST Cefiderocol 30ug (FDC30)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

This is a clearance letter for an Antimicrobial Susceptibility Test Disc (HardyDisk AST Cefiderocol 30ug). This type of device does not involve AI/ML. As such, the requested information (acceptance criteria, study details, human reader performance, ground truth, training set information) is not applicable.

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