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510(k) Data Aggregation

K Number

Device Name

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

Manufacturer

DADE BEHRING, INC.

Date Cleared

2000-10-11

(55 days)

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Regulation Number

Type

Panel

Clinical Chemistry

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N/A

Why did this record match?

Device Name :

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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