AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel— 510(k) K242540

Name: FDA 510(k) clearance K242540
Creator: U.S. Food and Drug Administration
Published: 2024-09-27

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K242540 for AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel, Substantially Equivalent on 2024-09-27. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2024-08-26
Decision date: 2024-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFT

view all

More clearances from Hangzhou AllTest Biotech Co., Ltd.

view all

K260342 — AllTest Strep A Rapid Test2026-04-30
K252607 — AllTest Urinary Tract Infection Test2025-10-30
K251053 — Shinetell PlusTM Digital Early Pregnancy Test2025-07-15
K242576 — AllTest Viral Transport Medium2025-04-04
K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup2025-04-04

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