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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

GLUTARTEST 1 REAGENT STRIP

Manufacturer

INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

Date Cleared

2001-01-22

(203 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

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N/A

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N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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