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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

PLANNED SOPHIED CLASSIC

Manufacturer

Date Cleared

1997-02-05

(250 days)

Product Code

Regulation Number

Type

Panel

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N/A

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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