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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

HANDHELD BASE UNIT

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2008-01-31

(108 days)

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Regulation Number

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Panel

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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