| Healgen® Accurate Oral Fluid Drug Test (K253705) | Healgen Scientific,, LLC | 2026-03-16 |
| LYHER® Oral fluid Multi-Drug Test Kit (Cube) (K240287) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 |
| 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. | 2018-12-17 |
| OralTox Oral fluid Drug Test (K181305) | Premier Biotech, Inc. | 2018-09-20 |
| OralTox Oral Fluid Drug Test (K171403) | Premier Biotech, Inc. | 2018-02-02 |
| 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) (K161044) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 |
| WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) (K132630) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 |
| UNISCAN -DOA SYSTEM (K080347) | Taiwan Unison Biotech, Inc. | 2008-10-09 |
| ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (K060355) | Acro Biotech, LLC | 2006-08-07 |
| MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (K060896) | Varian, Inc. | 2006-06-09 |
| ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (K053033) | Acro Biotech, LLC | 2006-06-06 |
| AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (K031497) | Amedica Biotech, Inc. | 2003-10-17 |
| STARTOX DRUG OF ABUSE SCREENING TEST (4) (K022388) | Starplex Scientific, Inc. | 2003-02-27 |
| INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST (K022501) | Alfa Scientific Designs, Inc. | 2002-11-13 |
| VERDICT-II (K022141) | Medtox Diagnostics, Inc. | 2002-07-30 |
| PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (K011185) | Psychemedics Corp. | 2002-01-24 |
| RAPIDONE-ECSTASY TEST (K013180) | American Bio Medica Corp. | 2001-11-26 |
| VERDICT -II METHAMPHETAMINE (K010226) | Medtox Diagnostics, Inc. | 2001-06-01 |
| BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST (K002265) | Branan Medical Corporation | 2000-11-27 |
| BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (K002587) | Branan Medical Corporation | 2000-11-22 |
| INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST (K994406) | Alfa Scientific Designs, Inc. | 2000-08-14 |
| INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST (K994400) | Alfa Scientific Designs, Inc. | 2000-08-04 |
| ONTRAK TESTCUP PRO-5, MODEL 1986678 (K001356) | Roche Diagnostics Corp. | 2000-07-10 |
| REDI-SCREEN (K993100) | Redwood Biotech, Inc. | 1999-10-06 |
| DIALYSIS SYS., PDS 400 & RO 400 (K781156) | Physio-Control Corp. | 1978-10-24 |
| KIDNEY, ARTIFICIAL (K781153) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-17 |
| CUTTER RESIFLEX FOLEY CATHETERS (K781140) | Cutler Laboratories, Inc. | 1978-09-07 |
| KIDNEY, ARTIFICIAL, C-DAK 2.0 (K781237) | Cordis Corp. | 1978-08-31 |
| KIDNEY, ARTIFICIAL, C-DAK 1.5 (K781238) | Cordis Corp. | 1978-08-31 |
| BANDAGE, COMPRESSION, FISTULAID (K781110) | Medical Device Laboratories | 1978-08-18 |
| A-V FISTULA NEEDLE (K781331) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-17 |