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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

FACTOR V LEIDEN KIT

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2003-12-17

(9 days)

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Regulation Number

Type

Panel

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N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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