| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2016-10-14 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | Assure Tech. Co., Ltd. | 2015-06-04 |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | 2015-04-24 |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 |
| K140665 | GenPrime Snap-Top Split Key Cup | Genprime, Inc. | 2014-12-08 |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-06-16 |
| K092268 | RANDOX BARITURATES ASSAY | Randox Laboratories, Ltd. | 2011-05-25 |
| K110515 | UCP DRUG SCREENING TEST CUPS | Ucp Biosciences, Inc. | 2011-04-20 |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Phamatech, Inc. | 2007-12-07 |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | Phamatech, Inc. | 2007-12-07 |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics | 2007-01-05 |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 |
| K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | ACON Laboratories, Inc. | 2005-05-06 |
| K043211 | ONLINE DAT BARBITURATES PLUS | Roche Diagnostics Corp. | 2004-12-29 |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | Ameditech, Inc. | 2004-12-29 |
| K041143 | RANDOX BARBITURATE ASSAY | Randox Laboratories, Ltd. | 2004-11-05 |
| K041712 | 'RAPIDTEC 4' TEST | American Bio Medica Corp. | 2004-11-03 |
| K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) | Lin-Zhi International, Inc. | 2004-05-19 |
| K033334 | PROFILE -ER | Medtox Diagnostics, Inc. | 2003-11-10 |
| K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | Lin-Zhi International, Inc. | 2003-11-03 |
| K023946 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE | ACON Laboratories, Inc. | 2003-02-05 |
| K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES | Sun Biomedical Laboratories, Inc. | 2002-04-25 |
| K020136 | VISUALINE BARBITURATES DIPSTRIP TEST | Sun Biomedical Laboratories, Inc. | 2002-03-20 |
| K012996 | BARBITURATES | Abbott Laboratories | 2002-03-20 |
| K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE | ACON Laboratories, Inc. | 2001-11-09 |
| K012133 | LIVESURE BARBITURATES SCREEN TEST | Pan Probe Biotech, Inc. | 2001-07-20 |
| K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| K010959 | VERDICT -II BAR; VERDICT -II BZO | Medtox Diagnostics, Inc. | 2001-04-13 |