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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

ELECSYS CA 125 II CALSET

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2001-01-12

(21 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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