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510(k) Data Aggregation

K Number

Device Name

REFACTO LABORATORY STANDARD

Manufacturer

THE GENETICS INSTITUTE

Date Cleared

2000-10-05

(64 days)

Product Code

Regulation Number

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Applicant Name (Manufacturer) :

THE GENETICS INSTITUTE

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

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