Product code DJC
- Device name
- Thin Layer Chromatography, Methamphetamine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3610
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026-03-16 |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 |
| 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 ... | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-17 |
| K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018-09-20 |
| K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018-02-02 |
| 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... | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 |
| K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 |
| K080347 | UNISCAN -DOA SYSTEM | Taiwan Unison Biotech, Inc. | 2008-10-09 |
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | Acro Biotech, LLC | 2006-08-07 |
| 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 |
| K013180 | RAPIDONE-ECSTASY TEST | American Bio Medica Corp. | 2001-11-26 |
| K010226 | VERDICT -II METHAMPHETAMINE | Medtox Diagnostics, Inc. | 2001-06-01 |
| K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | Branan Medical Corporation | 2000-11-27 |
| K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | Branan Medical Corporation | 2000-11-22 |
| K994406 | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-08-14 |
| K994400 | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-08-04 |
| K001356 | ONTRAK TESTCUP PRO-5, MODEL 1986678 | Roche Diagnostics Corp. | 2000-07-10 |
| K993100 | REDI-SCREEN | Redwood Biotech, Inc. | 1999-10-06 |
| K781156 | DIALYSIS SYS., PDS 400 & RO 400 | Physio-Control Corp. | 1978-10-24 |
| K781153 | KIDNEY, ARTIFICIAL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-17 |
| K781140 | CUTTER RESIFLEX FOLEY CATHETERS | Cutler Laboratories, Inc. | 1978-09-07 |
| K781237 | KIDNEY, ARTIFICIAL, C-DAK 2.0 | Cordis Corp. | 1978-08-31 |
| K781238 | KIDNEY, ARTIFICIAL, C-DAK 1.5 | Cordis Corp. | 1978-08-31 |
| K781110 | BANDAGE, COMPRESSION, FISTULAID | Medical Device Laboratories | 1978-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850013035684 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035677 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035400 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035417 | Identify®Diagnostics Drug Test Dips | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035424 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035530 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 00194346667574 | Equate | WAL-MART STORES, INC. | 2026-04-07 |
| 16936983149751 | Discover milti-drug12 drugs rapid test cup | Hangzhou AllTest Biotech Co., Ltd. | 2024-02-09 |
| 16936983149744 | Discover milti-drug 7 drugs rapid test cup | Hangzhou AllTest Biotech Co., Ltd. | 2024-02-08 |
| 16936983150634 | Discover milti-drug 8 drugs rapid test cup (urine) | Hangzhou AllTest Biotech Co., Ltd. | 2024-02-08 |
| 16936983144671 | Discover | Hangzhou AllTest Biotech Co., Ltd. | 2023-11-30 |
| 10612479258430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10694644100188 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100171 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100164 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100157 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100140 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100133 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100126 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100119 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100102 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100096 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100089 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100072 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100065 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100058 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100041 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100034 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100027 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100010 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |