Panels › Clinical Toxicology › Product code DIS · Class 2
Enzyme Immunoassay, Barbiturate
Regulation 862.3150
0510(k)s in 12 months (100 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in DIS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2016 | K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | DIS |
| Jun 4, 2015 | K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secob Assure Tech. Co., Ltd., CN | DIS |
| Apr 24, 2015 | K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC | DIS |
| Jan 13, 2015 | K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone Guangzhou Wondfo Biotech Co., Ltd., CN | DIS |
| Dec 8, 2014 | K140665 | GenPrime Snap-Top Split Key Cup Genprime, Inc. | DIS |
| Jun 16, 2014 | K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD Co-Innovation Biotech Co., Ltd., CN | DIS |
| May 25, 2011 | K092268 | RANDOX BARITURATES ASSAY Randox Laboratories, Ltd., GB | DIS |
| Apr 20, 2011 | K110515 | UCP DRUG SCREENING TEST CUPS Ucp Biosciences, Inc. | DIS |
| Dec 7, 2007 | K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC Phamatech, Inc. | DIS |
| Dec 7, 2007 | K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X Phamatech, Inc. | DIS |
| Jan 5, 2007 | K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics | DIS |
| Nov 17, 2005 | K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS Guangzhou Wondfo Biotech Co., Ltd. | DIS |
| May 6, 2005 | K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE ACON Laboratories, Inc. | DIS |
| Dec 29, 2004 | K043211 | ONLINE DAT BARBITURATES PLUS Roche Diagnostics Corp. | DIS |
| Dec 29, 2004 | K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II Ameditech, Inc. | DIS |
| Nov 5, 2004 | K041143 | RANDOX BARBITURATE ASSAY Randox Laboratories, Ltd., GB | DIS |
| Nov 3, 2004 | K041712 | 'RAPIDTEC 4' TEST American Bio Medica Corp. | DIS |
| May 19, 2004 | K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc. | DIS |
| Nov 10, 2003 | K033334 | PROFILE -ER Medtox Diagnostics, Inc. | DIS |
| Nov 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) Lin-Zhi International, Inc. | DIS |
| Feb 5, 2003 | K023946 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE ACON Laboratories, Inc. | DIS |
| Apr 25, 2002 | K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES Sun Biomedical Laboratories, Inc. | DIS |
| Mar 20, 2002 | K020136 | VISUALINE BARBITURATES DIPSTRIP TEST Sun Biomedical Laboratories, Inc. | DIS |
| Mar 20, 2002 | K012996 | BARBITURATES Abbott Laboratories | DIS |
| Nov 9, 2001 | K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE ACON Laboratories, Inc. | DIS |
| Jul 20, 2001 | K012133 | LIVESURE BARBITURATES SCREEN TEST Pan Probe Biotech, Inc. | DIS |
| May 29, 2001 | K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DIS |
| May 29, 2001 | K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DIS |
| Apr 20, 2001 | K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 Syva Co., Dade Behring, Inc. | DIS |
| Apr 13, 2001 | K010959 | VERDICT -II BAR; VERDICT -II BZO Medtox Diagnostics, Inc. | DIS |
| Apr 5, 2001 | K010561 | VERDICT -II BAR/BZO Medtox Diagnostics, Inc. | DIS |
| Jan 17, 2001 | K002331 | PROFILE-ER Medtox Diagnostics, Inc. | DIS |
| Dec 6, 2000 | K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I OraSure Technologies, Inc. | DIS |
| Nov 22, 2000 | K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST Branan Medical Corporation | DIS |
| Apr 18, 2000 | K000522 | SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST Drug Detection Devices, Ltd. | DIS |
| Apr 3, 2000 | K992451 | RAPIDONE- BARBITURATE TEST American Bio Medica Corp. | DIS |
| Apr 3, 2000 | K000459 | URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A Dade Behring, Inc. | DIS |
| Jun 28, 1999 | K990280 | BIONIKE AQ BARBITURATE TEST Bionike, Inc. | DIS |
| Jun 22, 1999 | K991440 | ROCHE COBAS INTEGRA SERUM BARBITURATES Roche Diagnostics Corp. | DIS |
| May 3, 1999 | K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES Roche Diagnostic Systems, Inc. | DIS |
| Apr 15, 1999 | K991084 | ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991076 | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR Princeton BioMeditech Corp. | DIS |
| Nov 18, 1998 | K982745 | AUTO-LYTE BARBITURATES EIA OraSure Technologies, Inc. | DIS |
| Sep 21, 1998 | K982152 | QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 Phamatech | DIS |
| Aug 18, 1998 | K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN Roche Diagnostic Systems, Inc. | DIS |
| Mar 3, 1998 | K980349 | QUICKPAC II ONE STEP BARBITURATE TEST Syntron Bioresearch, Inc. | DIS |
| Feb 12, 1998 | K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST Syntron Bioresearch, Inc. | DIS |
| Oct 2, 1997 | K973047 | ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST Drial Consultants, Inc. | DIS |
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