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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS

Manufacturer

BIONOSTICS, INC.

Date Cleared

2000-09-18

(33 days)

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Regulation Number

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Panel

Clinical Chemistry

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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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