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510(k) Data Aggregation

K Number

Device Name

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

Manufacturer

MORE DIAGNOSTICS

Date Cleared

1997-04-17

(44 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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