Cleared Traditional

MICROZYME THC ENZYME IMMUNOASSAY TEST KIT

K904635 · Immunotech Corp. · Toxicology
Nov 1990
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K904635 is an FDA 510(k) clearance for the MICROZYME THC ENZYME IMMUNOASSAY TEST KIT, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on November 1, 1990, 21 days after receiving the submission on October 11, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K904635 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1990
Decision Date November 01, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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