Cleared Traditional

K182738 - Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) (FDA 510(k) Clearance)

K182738 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology device

Mar 2019

Decision

180d

Days

Class 2

Risk

K182738 is an FDA 510(k) clearance for the Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine). This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 27, 2019, 180 days after receiving the submission on September 28, 2018.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K182738 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2018
Decision Date	March 27, 2019
Days to Decision	180 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF