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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

AllTest Urinary Tract Infection Test

Manufacturer

Hangzhou Alltest Biotech Co.,Ltd

Date Cleared

2025-10-30

(73 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The AllTest Urinary Tract Infection Test is for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

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