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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

Manufacturer

POINTE SCIENTIFIC, INC.

Date Cleared

2003-03-31

(117 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter and an Indications for Use statement for a medical device. It does not contain information about acceptance criteria, study details, or device performance as requested in the prompt. Therefore, I cannot provide the requested information based on this input.

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