| IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045) | Diagnostic Products Corp. | 2006-12-05 |
| ESA LEADCARE II LEAD CONTROL (K063398) | Bionostics, Inc. | 2006-12-05 |
| FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (K061617) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-11-22 |
| VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V (K062637) | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062077) | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123) | Ortho-Clinical Diagnostics, Inc. | 2006-11-16 |
| INNOVACON SPECTRUM II TEST CARD (K061718) | Innovacon, Inc. | 2006-11-13 |
| BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 (K061922) | Sentech Korea Corp. | 2006-10-30 |
| QUANTIMETRIX NICOSURE COTININE URINE CONTROL (K062942) | Quantimetrix Corp. | 2006-10-30 |
| LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS (K063024) | Lin-Zhi International, Inc. | 2006-10-30 |
| ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS (K061005) | Applied Dna Technologies, Inc. | 2006-10-04 |
| METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS (K062242) | Lin-Zhi International, Inc. | 2006-09-29 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (K062162) | Dade Behring, Inc. | 2006-09-14 |
| DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (K062182) | Dade Behring, Inc. | 2006-09-14 |
| DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (K062199) | Dade Behring, Inc. | 2006-09-06 |
| DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (K062121) | Dade Behring, Inc. | 2006-08-25 |
| ONLINE TDM PROCAINAMIDE (K060773) | Roche Diagnostics Corp. | 2006-08-23 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191) | Dade Behring, Inc. | 2006-08-21 |
| UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (K061457) | Ucp Biosciences, Inc. | 2006-08-21 |
| TDM N-ACETYLPROCAINAMIDE (K060738) | Roche Diagnostics Corp. | 2006-08-16 |
| ONLINE VALPROIC ACID (K060690) | Roche Diagnostics Corp. | 2006-08-08 |
| ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (K060355) | Acro Biotech, LLC | 2006-08-07 |
| RAPIDONE-BUPRENORPHINE TEST (K060760) | American Bio Medica Corp. | 2006-08-07 |
| ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (K060810) | Ind Diagnostic, Inc. | 2006-08-07 |
| DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024) | Dade Behring, Inc. | 2006-07-28 |
| ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (K060354) | Acro Biotech, LLC | 2006-07-28 |
| INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST (K060527) | Alfa Scientific Designs, Inc. | 2006-07-25 |
| MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 (K051958) | Mp Biomedicals, LLC | 2006-07-21 |
| AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 (K061556) | Amedica Biotech, Inc. | 2006-07-21 |
| QMS TOBRAMYCIN (K060998) | Seradyn, Inc. | 2006-07-21 |
| DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI (K061792) | Dade Behring, Inc. | 2006-07-18 |
| DIMENSION VISTA FLEX REAGENT CARTRIDGES (K061655) | Dade Behring, Inc. | 2006-07-10 |
| TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (K060788) | Biosite Incorporated | 2006-07-10 |
| CHOLINESTERASE GEN.2 TEST SYSTEM (K061093) | Roche Diagnostics Corp. | 2006-07-03 |
| TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791) | Biosite Incorporated | 2006-06-22 |
| DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (K061503) | Dade Behring, Inc. | 2006-06-22 |
| RAPIDONE-COCAINE-150 TEST (K053422) | American Bio Medica Corp. | 2006-06-15 |
| MULTIGENT GENTAMICIN (K060709) | Seradyn, Inc. | 2006-06-15 |
| ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 (K053037) | Acro Biotech, LLC | 2006-06-15 |
| MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (K060896) | Varian, Inc. | 2006-06-09 |
| FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (K052197) | W.H.P.M., Inc. | 2006-06-09 |
| ONLINE TDM TOBRAMYCIN (K060853) | Roche Diagnostics Corp. | 2006-06-09 |
| ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (K053033) | Acro Biotech, LLC | 2006-06-06 |
| ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 (K053034) | Acro Biotech, LLC | 2006-06-06 |
| AXSYM DIGOXIN III (K061249) | Abbott Laboratories | 2006-06-02 |
| PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K060645) | Roche Diagnostics Corp. | 2006-05-30 |
| RAPIDTOX (K053359) | American Bio Medica Corp. | 2006-05-25 |
| DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 (K053337) | Dade Behring, Inc. | 2006-05-19 |
| DIMENSION TACR CALIBRATOR, MODEL DC107 (K060503) | Dade Behring, Inc. | 2006-05-18 |
| MEDTOX OXYCODONE (K060351) | Medtox Diagnostics, Inc. | 2006-05-12 |
| BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 (K060343) | Sentech Korea Corp. | 2006-05-11 |
| ENZYME IMMUNOASSAY, VANCOMYCIN (K060586) | Roche Diagnostics Corp. | 2006-05-11 |
| ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (K053035) | Acro Biotech, LLC | 2006-05-05 |
| BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS (K060761) | Akers Biosciences, Inc. | 2006-04-28 |
| RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC (K052520) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-04-24 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE (K060466) | ACON Laboratories, Inc. | 2006-04-21 |
| METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K051058) | Lin-Zhi International, Inc. | 2006-03-29 |
| ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS (K050945) | Lin-Zhi International, Inc. | 2006-03-29 |
| MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K060417) | Quantimetrix Corp. | 2006-03-21 |
| POCKET BREATHALYZER. CONNECTABLES (K052448) | Connectables, LLC | 2006-02-23 |
| DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (K053108) | Dade Behring, Inc. | 2006-02-16 |
| FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (K052882) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-02-15 |
| ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (K053032) | Acro Biotech, LLC | 2006-02-09 |
| BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 (K053332) | Sentech Korea Corp. | 2006-01-20 |
| FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K052115) | First Check Diagnostics, LLC | 2005-12-29 |
| QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (K052826) | Seradyn, Inc. | 2005-12-23 |
| BREATHKEY MODEL G10/BREATHKEY MODEL G30X (K052804) | Omega Point Systems, LLC | 2005-12-09 |
| AMEDITECH DRUGSMARTCUP (K053175) | Ameditech, Inc. | 2005-12-08 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (K051161) | Quest Diagnostics, Inc. | 2005-11-22 |
| IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS (K051578) | Immunalysis Corporation | 2005-11-18 |
| QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (K051211) | Seradyn, Inc. | 2005-11-18 |
| ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS (K050024) | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 |
| QMS AMIKACIN REAGENTS (K052815) | Seradyn, Inc. | 2005-11-01 |
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341) | Bio-Rad Laboratories, Inc. | 2005-10-27 |
| SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS (K050394) | Medtox Diagnostics, Inc. | 2005-10-25 |
| IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS (K051579) | Immunalysis Corporation | 2005-10-21 |
| IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS (K051626) | Immunalysis Corporation | 2005-10-13 |
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |
| IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS (K051577) | Immunalysis Corporation | 2005-10-04 |
| DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (K052015) | Dade Behring, Inc. | 2005-09-12 |
| FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K051966) | Worldwide Medical, LLC | 2005-09-07 |
| INVADER UGT1A1 MOLECULAR ASSAY (K051824) | Third Wave Technologies, Inc. | 2005-08-18 |
| LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK (K052053) | Bio-Rad | 2005-08-09 |
| IMMUNALYSIS COCAINE ELISA FOR HAIR (K050465) | Immunalysis Corporation | 2005-08-04 |
| RAPID READER (K041696) | American Bio Medica Corp. | 2005-07-12 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (K042725) | Quest Diagnostics, Inc. | 2005-07-06 |
| MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088) | Lin-Zhi International, Inc. | 2005-06-24 |
| ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE (K050936) | ACON Laboratories, Inc. | 2005-06-24 |
| SENTINEL CHOLINESTERASE LIQUID (K051444) | Sentinel Ch. Srl | 2005-06-20 |
| ADVIA IMS LITHIUM ASSAY (K050374) | Bayer Healthcare, LLC | 2005-06-15 |
| SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT (K051307) | Beckman Coulter, Inc. | 2005-06-13 |
| OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS (K050733) | Lin-Zhi International, Inc. | 2005-06-13 |
| ON TRAK TESTCARD (K051235) | Varian, Inc. | 2005-06-08 |
| ON CALL MULTI-DRUG HOME TEST CUP (K050878) | ACON Laboratories, Inc. | 2005-06-08 |
| MAS IMMUNOSUPPRESSANT CONTROLS (K051074) | Microgenics Corp. | 2005-06-06 |
| RANDOX BENZODIAZEPINE CLASS ASSAY (K050179) | Randox Laboratories, Ltd. | 2005-05-17 |
| NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE (K050594) | Nano-Ditech Co. | 2005-05-15 |
| RAPID ONE STEP BUPRENORPHINE TEST CARD (K042988) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-12 |
| FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (K042990) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-10 |
| ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE (K050593) | ACON Laboratories, Inc. | 2005-05-06 |