Cleared Traditional

Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

K232732 · Co-Innovation Biotech Co., Ltd. · Toxicology
Jan 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K232732 is an FDA 510(k) clearance for the Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on January 17, 2024, 132 days after receiving the submission on September 7, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K232732 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2023
Decision Date January 17, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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