AllTest Multi-Drug Rapid Test Cup +3 more— 510(k) K233019

Name: FDA 510(k) clearance K233019
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K233019 for AllTest Multi-Drug Rapid Test Cup +3 more, Substantially Equivalent on 2023-12-13. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2023-09-22
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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