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510(k) Data Aggregation

K Number

Device Name

FASTPACK HCG IMMUNOASSAY

Manufacturer

Date Cleared

2007-12-06

(113 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

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Device Name :

FASTPACK HCG IMMUNOASSAY

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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