Product code DJC— Clinical Toxicology
A-V FISTULA NEEDLE
- Classification name
- Thin Layer Chromatography, Methamphetamine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code DJC
FDA has cleared devices under product code DJC between 1978 and 2026, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2018
- 2016
- 2013
- 2008
- 2006
- 2003
- 2002
- 2001
- 2000
- 1999
- 1978
Top applicants under product code DJC
Recent clearances under product code DJC
- K253705 — Healgen® Accurate Oral Fluid Drug Test
- K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube)
- K180878 — 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
- K181305 — OralTox Oral fluid Drug Test
- K171403 — OralTox Oral Fluid Drug Test
- K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
- K080347 — UNISCAN -DOA SYSTEM
- K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
- K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
- K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
- K031497 — AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
- K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4)
- K022501 — INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
- K022141 — VERDICT-II
- K011185 — PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
- K013180 — RAPIDONE-ECSTASY TEST
- K010226 — VERDICT -II METHAMPHETAMINE
- K002265 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
- K002587 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
- K994406 — INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
- K994400 — INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
- K001356 — ONTRAK TESTCUP PRO-5, MODEL 1986678
- K993100 — REDI-SCREEN
- K781156 — DIALYSIS SYS., PDS 400 & RO 400
- K781153 — KIDNEY, ARTIFICIAL
- K781140 — CUTTER RESIFLEX FOLEY CATHETERS
- K781237 — KIDNEY, ARTIFICIAL, C-DAK 2.0
- K781238 — KIDNEY, ARTIFICIAL, C-DAK 1.5
- K781110 — BANDAGE, COMPRESSION, FISTULAID
- K781331 — A-V FISTULA NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.