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510(k) Data Aggregation

K Number

Device Name

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

Manufacturer

Date Cleared

2001-05-17

(15 days)

Product Code

Regulation Number

Type

Panel

Toxicology (TX)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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