Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AllTest Strep A Rapid Test

K-Number: K260342 · 2026-04-30

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2026-04-30
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AllTest Strep A Rapid Test is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-30 under approval number K260342. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllTest Strep A Rapid Test?

AllTest Strep A Rapid Test is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K260342.

When was AllTest Strep A Rapid Test approved by the FDA?

AllTest Strep A Rapid Test received FDA 510(k) clearance on 2026-04-30, under approval number K260342.

What company makes AllTest Strep A Rapid Test?

AllTest Strep A Rapid Test is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for AllTest Strep A Rapid Test?

The FDA product code for AllTest Strep A Rapid Test is GTY.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑