510(k) K253705

Device: Healgen® Accurate Oral Fluid Drug Test
Applicant: Healgen Scientific,, LLC
510(k) number: K253705
Product code: DJC
Decision: Substantially Equivalent (SESE)
Decision date: 2026-03-16
Date received: 2025-11-24
Regulation: 862.3610
Classification name: Thin Layer Chromatography, Methamphetamine
Medical specialty: Clinical Toxicology
Review panel: Clinical Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Fang Jianqiu
Address: 3818 Fuqua St. Houston TX US 77047 77047

FDA Registration Numbers

3010800486
3012725363
2246703
1063851
3005360469
3036649420
3013684380
3043127647
3011522054
3009414546
3005641941
3031823359
2087033
3009585529
3023296261
1050155
3005174594
2090110
3013679502
2032364
3007126977
3030413233
3010934853
3017904598
2060833
3005345870
1832216
2915274
3009473156
3010220539
3008852306
3024463179
3021186226
3010852191
3043196750
3014607865
3008054239
3004493545
3030648160
3011559327
3008416529
3008517993
3012073813
3004175381
3009238284
3005984081
3004987297
3003917514
2029372
3016610313
2027969
2030633
3027519599

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DJC

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K240287	LYHER® Oral fluid Multi-Drug Test Kit (Cube)	Hangzhou Laihe Biotech Co., Ltd.	2025-03-18
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K060896	MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT	Varian, Inc.	2006-06-09
K053033	ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000	Acro Biotech, LLC	2006-06-06
K031497	AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST	Amedica Biotech, Inc.	2003-10-17
K022388	STARTOX DRUG OF ABUSE SCREENING TEST (4)	Starplex Scientific, Inc.	2003-02-27
K022501	INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST	Alfa Scientific Designs, Inc.	2002-11-13
K022141	VERDICT-II	Medtox Diagnostics, Inc.	2002-07-30
K011185	PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY	Psychemedics Corp.	2002-01-24