AllTest Strep A Rapid Test— 510(k) K260342

Clearance details

Applicant

Hangzhou AllTest Biotech Co., Ltd.

Product code

Code GTY

Device class

Class 1

Regulation

21 CFR 866.3740

Advisory panel

Microbiology

Date received

2026-02-02

Decision date

2026-04-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, CN

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• K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup2025-04-04
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Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →