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510(k) Data Aggregation

K Number

Device Name

REP 3 FLUR SPE-60 KIT

Manufacturer

HELENA LABORATORIES

Date Cleared

1996-12-23

(47 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

REP 3 FLUR SPE-60 KIT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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