Cleared Traditional

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)

K981584 · Roche Diagnostic Systems, Inc. · Toxicology
May 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K981584 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT), a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on May 28, 1998, 24 days after receiving the submission on May 4, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K981584 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1998
Decision Date May 28, 1998
Days to Decision 24 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

Similar Devices — LDJ Enzyme Immunoassay, Cannabinoids

All 149
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. · Jan 2024
LYHER? Urine Marijuana (THC) Test Kit (Strip), LYHER? Urine Marijuana (THC) Test Kit (Cassette)
K232604 · Hangzhou Laihe Biotech Co., Ltd. · Jan 2024
Healgen? Accurate Oral Fluid Drug Test, Healgen? Accurate Oral Fluid Drug Test COT
K223162 · Healgen Scientific, LLC · Mar 2023
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
K192515 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Oct 2019
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
K153741 · Hangzhou Clongene Biotech Co., Ltd. · Mar 2016
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
K152643 · Nantong Egens Biotech Co., Ltd. · Nov 2015