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510(k) Data Aggregation

K Number

Device Name

PLANNED SOPHIED CLASSIC

Manufacturer

Date Cleared

1997-02-05

(250 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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Device Name :

PLANNED SOPHIED CLASSIC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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