Cleared Traditional

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

K180878 · Shanghai Venture Bio-Tech Co., Ltd. · Toxicology

Dec 2018

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K180878 is an FDA 510(k) clearance for the BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx, a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Shanghai Venture Bio-Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 17, 2018, 258 days after receiving the submission on April 3, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number	K180878 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2018
Decision Date	December 17, 2018
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF