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510(k) Data Aggregation

K Number

Device Name

WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

Manufacturer

Date Cleared

2000-02-15

(57 days)

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Regulation Number

Type

Panel

Clinical Chemistry

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N/A

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Device Name :

WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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