K260342
- 510(k) number
- K260342
- Device name
- AllTest Strep A Rapid Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- GTY — Antigens, All Groups, Streptococcus Spp.
- Decision date
- 2026-04-30
- Date received
- 2026-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260342.pdf
Official FDA record: K260342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.