| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE (K092967) | Pathwork Diagnostics | 2010-06-08 |
| ADVIA CHEMISTRY SALICYLATE REAGENT (K093939) | Siemens Healthcare Diagnostics | 2010-05-19 |
| THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY (K093114) | Microgenics Corp. | 2010-05-12 |
| ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (K092048) | Biosite Incorporated | 2010-04-19 |
| AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA (K100108) | Amedica Biotech, Inc. | 2010-04-14 |
| DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (K093441) | Siemens Healthcare Diagnostics | 2010-04-07 |
| PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM (K100023) | Medtox Diagnostics, Inc. | 2010-04-05 |
| LIQUICHEK OPIATE CONTROL (K093577) | Bio-Rad Laboratories | 2010-03-12 |
| UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; (K091612) | Ucp Biosciences, Inc. | 2010-02-24 |
| AMPHETAMINES II (K083764) | Roche Diagnostics Corp. | 2010-02-03 |
| MISSION BREATH ALCOHOL DETECTOR (K093143) | ACON Laboratories, Inc. | 2010-01-28 |
| ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 (K091884) | Ark Diagnostics, Inc. | 2009-12-09 |
| ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714) | Skyfine Inc. Limited | 2009-11-18 |
| CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459) | Chromsystems Instruments & Chemicals GmbH | 2009-11-17 |
| ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 (K091653) | Ark Diagnostics, Inc. | 2009-11-02 |
| UCP HOME DRUG SCREENING TESTS (K091588) | Ucp Biosciences, Inc. | 2009-09-04 |
| BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP (K082977) | Mk Bio, Inc. | 2009-08-20 |
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS (K090844) | Lin-Zhi International, Inc. | 2009-07-30 |
| PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM (K091454) | Medtox Diagnostics, Inc. | 2009-07-24 |
| LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (K090766) | Lifeloc Technologies, Inc. | 2009-07-23 |
| QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (K091617) | Thermo Fisher Scientific | 2009-07-17 |
| ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 (K090939) | Roche Diagnostics | 2009-06-18 |
| ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (K090900) | Siemens Healthcare Diagnostics | 2009-06-01 |
| QMS LIDOCAINE (K090282) | Thermo Fisher Scientific, Inc. | 2009-05-29 |
| ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (K081938) | Genzyme Diagnostics P.E.I., Inc. | 2009-05-01 |
| TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 (K083799) | Ark Diagnostics, Inc. | 2009-04-16 |
| ALCO TUBE PLUS (K082080) | Alcotest Quebec | 2009-04-01 |
| EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487) | Siemens Healthcare Diagnostics | 2009-03-30 |
| BACTRACK SELECT BREATHALYZER, MODEL S80 (K090067) | Khn Solutions, LLC | 2009-03-24 |
| BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (K083801) | Khn Solutions, LLC | 2009-03-19 |
| MEDTOXSCAN (K080635) | Medtox Diagnostics, Inc. | 2009-02-13 |
| RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 (K080436) | Quantrx Biomedical Corporation | 2009-02-11 |
| EQ-PRC LC WARFARIN GENOTYPING KIT (K073071) | Trimgen Corporation | 2009-02-06 |
| APIERON INSIGHT ENO SYSTEM (K083617) | Apieron, Inc. | 2009-01-27 |
| DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (K081378) | Thermo Fisher Scientific | 2009-01-14 |
| RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 (K080455) | Quantrx Biomedical Corporation | 2008-12-31 |
| ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953) | Biokit, S.A. | 2008-12-22 |
| BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS (K081008) | Lin-Zhi International, Inc. | 2008-12-22 |
| IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) (K081855) | Canada, Inc. | 2008-12-19 |
| AMEDICA DRUG SCREEN TEST CUP (K082898) | Amedica Biotech, Inc. | 2008-12-19 |
| KEY RING ALCOHOL BREATHALYZER (K082086) | The Ashley Collection, Inc. | 2008-12-19 |
| CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS (K081083) | Thermo Fisher Scientific | 2008-12-19 |
| DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (K082001) | Diazyme Laboratories | 2008-12-05 |
| BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, (K080467) | Applied Dna Technologies, Inc. | 2008-11-25 |
| FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD (K082508) | Branan Medical Corporation | 2008-11-21 |
| IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL (K080057) | Novx Systems, Inc. | 2008-10-31 |
| DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857) | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| UNISCAN -DOA SYSTEM (K080347) | Taiwan Unison Biotech, Inc. | 2008-10-09 |
| ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 (K081231) | Abbott Laboratories | 2008-09-26 |
| ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696) | Abbott Laboratories | 2008-09-11 |
| DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (K082030) | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 |
| AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ (K080872) | Amedica Biotech, Inc. | 2008-08-19 |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST (K080896) | Pathwork Diagnostics, Inc. | 2008-07-30 |
| ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR (K080848) | Q3 Innovations, LLC | 2008-07-25 |
| ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (K073720) | Osmetech Molecular Diagnostics | 2008-07-17 |
| QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (K080381) | Quest Diagnostics, Inc. | 2008-06-25 |
| RAPID TOX CUP (K073078) | American Bio Medica Corp. | 2008-05-30 |
| MAS TOX CONTROL (K080085) | Thermo Fisher Scientific | 2008-04-30 |
| HOMECHECK MULTIPLE DRUG CUP TEST (K071489) | Tianjin New Bay Bioresearch Co., Ltd. | 2008-03-28 |
| CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183) | Roche Diagnostics Corp. | 2008-03-25 |
| COBAS LITHIUM (K063684) | Roche Diagnostics Corp. | 2008-03-21 |
| ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036) | Biokit, S.A. | 2008-03-19 |
| APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM (K073265) | Apieron, Inc. | 2008-03-14 |
| DRAEGER ALCOTEST 6510 (K063443) | Drager Safety | 2008-03-11 |
| NIOX MINO (K072816) | Aerocrine AB | 2008-03-03 |
| MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (K072257) | More Diagnostics | 2008-01-30 |
| INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (K073014) | Autogenomics, Incorporated | 2008-01-23 |
| REDLINE ALCOHOL BREATH TESTER (K072953) | Redline Products (Pty) , Ltd. | 2008-01-07 |
| LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (K072721) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| AT HOME DRUG TEST MODELS, 9308T AND 9308X (K070009) | Phamatech, Inc. | 2007-12-07 |
| QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC (K070098) | Phamatech, Inc. | 2007-12-07 |
| MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (K062575) | Princeton BioMeditech Corp. | 2007-11-26 |
| PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (K063145) | Thermo Electron OY | 2007-10-17 |
| LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL (K063705) | Thermo Electron OY | 2007-10-09 |
| CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (K063131) | Thermo Electron OY | 2007-10-05 |
| ARCHITECT SIROLIMUS ASSAY (K070822) | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| UCP MULTIPLE DRUG SCREEN TEST CUPS (K072062) | Ucp Biosciences, Inc. | 2007-09-20 |
| VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (K070804) | Nanosphere, Inc. | 2007-09-17 |
| BACTRACK LCD ALCOHOL DETECTOR (K071067) | Khn Solutions, LLC | 2007-09-14 |
| ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (K071644) | Roche Diagnostics Corp. | 2007-09-12 |
| ETOH FLEX REAGENT CARTRIDGE (DF22) (K071811) | Dade Behring, Inc. | 2007-08-24 |
| SENTINEL LITHIUM ASSAY (K070987) | SENTINEL CH. SpA | 2007-08-02 |
| DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (K070853) | Dade Behring, Inc. | 2007-06-13 |
| ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810) | Biokit, S.A. | 2007-06-08 |
| IMDX SYSTEMS (K063699) | Novx Systems, Inc. | 2007-06-01 |
| SERADYN QMS TOPIRAMATE (K070645) | Seradyn, Inc. | 2007-05-17 |
| MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE (K063545) | Alfa Scientific Designs, Inc. | 2007-05-07 |
| RMI LCD ALCOHOL DETECTOR (K062545) | Resource Management International, LLC | 2007-04-09 |
| STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (K062565) | Princeton BioMeditech Corp. | 2007-02-20 |
| ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520) | Roche Diagnostics | 2007-02-16 |
| QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (K062966) | Seradyn, Inc. | 2007-01-12 |
| VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062165) | Ortho-Clinical Diagnostics | 2007-01-05 |
| VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K063164) | Ortho-Clinical Diagnostics, Inc. | 2006-12-28 |
| VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062285) | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (K063015) | Ameditech, Inc. | 2006-12-20 |
| QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA (K062929) | Quest Diagnostics, Inc. | 2006-12-18 |
| BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (K062971) | Akers Biosciences, Inc. | 2006-12-18 |
| VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III (K062460) | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 |
| AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 (K063379) | Amedica Biotech, Inc. | 2006-12-11 |