AllTest Strep A Rapid Test— 510(k) K260342

Name: FDA 510(k) clearance K260342
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K260342 for AllTest Strep A Rapid Test, Substantially Equivalent on 2026-04-30. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 1.

Summary

Hangzhou AllTest Biotech's AllTest Strep A Rapid Test is filed under product code GTY (Antigens, All Groups, Streptococcus Spp.).

Class I, 21 CFR 866.3740. It came in as a Traditional 510(k), and Microbiology is both the classification panel and the review panel.

Hangzhou AllTest Biotech filed from Hangzhou, China. Review took 87 calendar days (February 2 to April 30, 2026).

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Product 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

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTY

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K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip2025-11-26
K212623 — Healgen Strep A Rapid Test Strip (Throat Swab)2022-03-16
K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer2017-12-21
K141775 — SOFIA (R) STREP A+ FIA2014-12-16
K133343 — WONDFO RAPID STREP A TEST2014-01-31

More clearances from Hangzhou AllTest Biotech Co., Ltd.

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Adverse events under product code GTY

product code GTY

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.