DJC · Class II · 21 CFR 862.3610

FDA Product Code DJC: Thin Layer Chromatography, Methamphetamine

Leading manufacturers include Premier Biotech, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Cordis Corp..

31
Total
31
Cleared
133d
Avg days
1978
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 262d recently vs 124d historically

FDA 510(k) Cleared Thin Layer Chromatography, Methamphetamine Devices (Product Code DJC)

31 devices
1–24 of 31
Cleared Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
K253705
Healgen Scientific, LLC
Toxicology · 112d
Cleared Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
K240287
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 411d
Cleared Dec 17, 2018
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 · 258d
Cleared Sep 20, 2018
OralTox Oral fluid Drug Test
K181305
Premier Biotech, Inc.
Toxicology · 126d
Cleared Feb 02, 2018
OralTox Oral Fluid Drug Test
K171403
Premier Biotech, Inc.
Toxicology · 266d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Oct 17, 1978
KIDNEY, ARTIFICIAL
K781153
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 99d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 2.0
K781237
Cordis Corp.
Toxicology · 42d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 1.5
K781238
Cordis Corp.
Toxicology · 42d
Cleared Aug 17, 1978
A-V FISTULA NEEDLE
K781331
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 15d

About Product Code DJC - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code DJC since 1978, with 31 receiving FDA clearance (average review time: 133 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DJC Product Code

Recent submissions under DJC have taken an average of 262 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.

DJC devices are reviewed by the Toxicology panel. Browse all Toxicology devices →