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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

WAKO HDL-C/LDL-C CALIBRATOR

Manufacturer

WAKO CHEMICALS, USA, INC.

Date Cleared

2000-06-01

(64 days)

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Regulation Number

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Panel

Clinical Chemistry

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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