Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- DJREnzyme Immunoassay, Methadone2Product Code
- PFTReagents For Molecular Diagnostic Test Systems1Product Code
- QKTClozapine Test System2Product Code
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method2Product Code
- DIDBacillus Subtilis Microbiology Assay, Tobramycin2Product Code
- DIEHeavy Metals Control Materials1Product Code
- DIFDrug Mixture Control Materials1Product Code
- DIGCholinesterase Test Paper1Product Code
- DIHColorimetry, Cholinesterase1Product Code
- DIJLead, Delta Amino Levulinic Acid2Product Code
- DIKThin Layer Chromatography, Quinine1Product Code
- DILRadioimmunoassay, Primidone2Product Code
- DIMGas Chromatography, Salicylate2Product Code
- DINGas Chromatography, Cocaine2Product Code
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites2Product Code
- DIPEnzyme Immunoassay, Diphenylhydantoin2Product Code
- DIQRadioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DIRFree Radical Assay, Cocaine2Product Code
- DISEnzyme Immunoassay, Barbiturate2Product Code
- DITThin Layer Chromatography, Amphetamine2Product Code
- DIWHemagglutination Inhibition, Methadone2Product Code
- DIXThin Layer Chromatography, Phenobarbital2Product Code
- DIYGas Chromatography, Ethosuximide2Product Code
- DIZDelayed Analysis, Alcohol2Product Code
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.2Product Code
- DJCThin Layer Chromatography, Methamphetamine2Product Code
- DJDEnzyme Immunoassay, Primidone2Product Code
- DJEThin Layer Chromatography, Salicylate2Product Code
- DJFGas Chromatography, Opiates2Product Code
- DJGEnzyme Immunoassay, Opiates2Product Code
- DJHGas Chromatography, Phenobarbital2Product Code
- DJIAntiserum, Gentamicin2Product Code
- DJJFluorometry, Morphine2Product Code
- DJKDigitoxin Control Serum, Ria1Product Code
- DJLFree Radical Assay, Amphetamine2Product Code
- DJNMercury Dithiazone, Colorimetry, Barbiturate2Product Code
- DJPRadioimmunoassay, Amphetamine2Product Code
- DJQTest Reagents For Phenothiazine2Product Code
- DJXRadioimmunoassay, Ethosuximide2Product Code
- DJZDevices, Breath Trapping, Alcohol1Product Code
- DKAAntiserum, Digoxin2Product Code
- DKBCalibrators, Drug Mixture2Product Code
- DKCAlcohol Control Materials1Product Code
- DKDBacillus Subtilis, Microbiological Assay, Gentamicin2Product Code
- DKEReagents, Test, Tetrahydrocannabinol2Product Code
- DKHGas Chromatography, Diphenylhydantoin2Product Code
- DKJColorimetry, Salicylate2Product Code
- DKNRadioimmunoassay, Barbiturate2Product Code
- DKPRadioimmunoassay, Phenobarbital2Product Code
- DKQAntiserum, Digitoxin2Product Code
- DKRThin Layer Chromatography, Methadone2Product Code
- DKTFree Radical Assay, Opiates2Product Code
- DKWTest Reagents For Sulphanimide Derivatives1Product Code
- DKXThin Layer Chromatography, Barbiturate2Product Code
- DKZEnzyme Immunoassay, Amphetamine2Product Code
- K240670DRI Ecstasy Plus Assay2Cleared 510(K)
- K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx2Cleared 510(K)
- K231137Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2Cleared 510(K)
- K200363Quidel Triage® TOX Drug Screen, 946002Cleared 510(K)
- K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel2Cleared 510(K)
- K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro2Cleared 510(K)
- K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)2Cleared 510(K)
- K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use2Cleared 510(K)
- K181945QuickScreen Pro Multi Drug Screening Test, Model 9395Z2Cleared 510(K)
- K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)2Cleared 510(K)
- K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests2Cleared 510(K)
- K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)2Cleared 510(K)
- K152908UCP COMPACT DRUG TESTS2Cleared 510(K)
- K152590ACCU NEWS Drug Screening Test Card/Urine Cup2Cleared 510(K)
- K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)2Cleared 510(K)
- K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)2Cleared 510(K)
- K151213UCP Drug Test Mini Cups2Cleared 510(K)
- K142855Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)2Cleared 510(K)
- K141748RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET2Cleared 510(K)
- K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set2Cleared 510(K)
- K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard2Cleared 510(K)
- K142580Chemtrue Multi-Panel DOA DIP Card Tests2Cleared 510(K)
- K141532CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE2Cleared 510(K)
- K131069QUICKSCREEN AMPHETINE 500 TEST2Cleared 510(K)
- K132812UCP MULTI-DRUG TEST KEY CUPS2Cleared 510(K)
- K133968WONDFO MULTI-DRUG URINE TEST CUP, PANEL2Cleared 510(K)
- K131653LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS2Cleared 510(K)
- K131110ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD2Cleared 510(K)
- K130082GENPRIME DRUGS OF ABUSE READER SYSTEM2Cleared 510(K)
- K131645INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)2Cleared 510(K)
- K131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS2Cleared 510(K)
- K122809Advin Multi-Drug Screen Test Cassette, Dip Card and Cup2Cleared 510(K)
- K121065POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE2Cleared 510(K)
- K130463UCP HOME DRUG SCREENING TEST; CARDS, CUPS2Cleared 510(K)
- K130811PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE2Cleared 510(K)
- K123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS2Cleared 510(K)
- K122961WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)2Cleared 510(K)
- K122419UCP HOME DRUG SCREENING TEST CUPS2Cleared 510(K)
- K122904WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;2Cleared 510(K)
- K121987WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST2Cleared 510(K)
- K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS2Cleared 510(K)
- K113046AMEDITECH IMMUTEST MILTI-DRUG SCREEN2Cleared 510(K)
- K111560WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST2Cleared 510(K)
- K110446ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID2Cleared 510(K)
- K101745THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY2Cleared 510(K)
- K092275RANDOX ECSTASY (MDMA) ASSAY2Cleared 510(K)
- K102203CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS2Cleared 510(K)
- K102210LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS2Cleared 510(K)
- K093664AMPHETAMINES II ASSAY2Cleared 510(K)
- K093114THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY2Cleared 510(K)
- K083764AMPHETAMINES II2Cleared 510(K)
- K091588UCP HOME DRUG SCREENING TESTS2Cleared 510(K)
- K080635MEDTOXSCAN2Cleared 510(K)
- K080057IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL2Cleared 510(K)
- K071489HOMECHECK MULTIPLE DRUG CUP TEST2Cleared 510(K)
- K063379AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C12202Cleared 510(K)
- K062077VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS2Cleared 510(K)
- K061617FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST2Cleared 510(K)
- K061718INNOVACON SPECTRUM II TEST CARD2Cleared 510(K)
- K063024LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS2Cleared 510(K)
- K061005ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS2Cleared 510(K)
- K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC2Cleared 510(K)
- K053359RAPIDTOX2Cleared 510(K)
- K053337DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 1092Cleared 510(K)
- K052882FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE2Cleared 510(K)
- K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP0010002Cleared 510(K)
- K052115FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY2Cleared 510(K)
- K053175AMEDITECH DRUGSMARTCUP2Cleared 510(K)
- K051161QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)2Cleared 510(K)
- K050394SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS2Cleared 510(K)
- K051579IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS2Cleared 510(K)
- K051966FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY2Cleared 510(K)
- K041696RAPID READER2Cleared 510(K)
- K051235ON TRAK TESTCARD2Cleared 510(K)
- K050540UCP RAPID DRUG SCREENING TESTS2Cleared 510(K)
- K050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III2Cleared 510(K)
- K043028EMIT II PLUS ECSTASY ASSAY2Cleared 510(K)
- K041822ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE2Cleared 510(K)
- K041743ACON TRI-FECT DRUG SCREEN TEST DEVICE2Cleared 510(K)
- K041685ACON MULTI-CLIN DRUG SCREEN TEST DEVICE2Cleared 510(K)
- K032575FIRST SIGN DRUG OF ABUSE SCREENING TEST2Cleared 510(K)
- K033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-70622Cleared 510(K)
- K040350RANDOX AMPHETAMINE CLASS ASSAY2Cleared 510(K)
- K040133URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE2Cleared 510(K)
- K040203MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF222Cleared 510(K)
- K040092AMEDITECH IMMU TEST DRUG SCREEN PANEL2Cleared 510(K)
- K033902ONTRAK TESTCUP II AND ONSITE CUPKIT2Cleared 510(K)
- K033659VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK2Cleared 510(K)
- K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)2Cleared 510(K)
- K031759ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD2Cleared 510(K)
- K031004SYVA EMIT II PLUS AMPHETAMINES ASSAY2Cleared 510(K)
- K023712ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST2Cleared 510(K)
- K023104AMEDICA DRUG SCREEN AMPHETAMINE TEST2Cleared 510(K)
- K022564INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST2Cleared 510(K)
- K021114'RAPIDTEC' 5A MULTIPLE DIP TEST2Cleared 510(K)
- K020869FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)2Cleared 510(K)
- K021006STARTOX DRUG OF ABUSE SCREENING TEST2Cleared 510(K)
- K020395AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)2Cleared 510(K)
- K014247TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 920022Cleared 510(K)
- K020313ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE2Cleared 510(K)
- K012745TRIAGE TOX DRUG SCREEN, CATALOG #940002Cleared 510(K)
- K012484AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE2Cleared 510(K)
- K012396ONTRAK TESTCARD 92Cleared 510(K)
- K011952DRUGS OF ABUSE MULTI-TEST STRIP2Cleared 510(K)
- K012110DRI ECSTASY ENZYME IMMUNOASSAY2Cleared 510(K)
- K012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C2292Cleared 510(K)
- K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE2Cleared 510(K)
- K012159RAPID DRUG SCREEN2Cleared 510(K)
- K011499VISUALINE AMPHETAMINE DIPSTRIP ASSAY2Cleared 510(K)
- K011609LIVESURE AMPHETAMINE SCREEN TEST2Cleared 510(K)
- K010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY2Cleared 510(K)
- K003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS2Cleared 510(K)
- K010564VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO2Cleared 510(K)
- K010645AT HOME DRUG TEST, MODEL 9063 T2Cleared 510(K)
- K004034MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC122Cleared 510(K)
- K003865COBAS INTEGRA AMPHETAMINES2Cleared 510(K)
- K002266BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST2Cleared 510(K)
- K002447MODIFICATION TO RAPID DRUG SCREEN 9-PANEL2Cleared 510(K)
- K994395INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST2Cleared 510(K)
- K994399INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST2Cleared 510(K)
- K001421ONTRAK TESTCUP 501, MODEL 30166332Cleared 510(K)
- K001417ONTRAK TESTCUP 502, MODEL 30166412Cleared 510(K)
- K001397QUICKSCREEN PRO DRUG CUP, MODEL 9195X2Cleared 510(K)
- K001225ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.2Cleared 510(K)
- K000606SYNCHRON SYSTEMS AMPHETAMINE REAGENT2Cleared 510(K)
- K994380CEDIA DAU AMPHASSURE ASSAY2Cleared 510(K)
- K000400SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST2Cleared 510(K)
- K000460URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A2Cleared 510(K)
- K992918STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I2Cleared 510(K)
- K992632IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM52Cleared 510(K)
- K994237AT HOME DRUG TEST, MODEL 90632Cleared 510(K)
- K990681DBSET MULTIDRUG SCREEN TEST KIT2Cleared 510(K)
- K992033MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL2Cleared 510(K)
- K990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE2Cleared 510(K)
- K990399ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 82Cleared 510(K)
- K990418ONTRAK TESTCUP-ER M2K2Cleared 510(K)
- K984525RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST2Cleared 510(K)
- K990337ONTRAK TESTCUP-5 M2K2Cleared 510(K)
- K983770'RAPID DRUG SCREEN' 9-PANEL2Cleared 510(K)
- K983699MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES2Cleared 510(K)
- K981705'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME2Cleared 510(K)
- K981504DBEST AMPHETAMINES TEST KIT2Cleared 510(K)
- K981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST2Cleared 510(K)
- K980865QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 91312Cleared 510(K)
- K974611MICRO-STRIP FOR AMPHETAMINE METABOLITES2Cleared 510(K)
- K972989STC METHAMPHETAMINE MICRO-PLATE EIA2Cleared 510(K)
- K973784TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS2Cleared 510(K)
- K973726FINGERPRINT DRUG SCREENING DEVICE2Cleared 510(K)
- K973075ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON2Cleared 510(K)
- K972891ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION2Cleared 510(K)
- K972032VISUALINE II METHAMPHETIMINE2Cleared 510(K)
- K970395QUIKSTRIP ONE STEP METHAMPHETAMINE2Cleared 510(K)
- K971218QUIKSTRIP ONE STEP AMPHETAMINE TEST2Cleared 510(K)
- K971109QUIKPAC II ONE STEP AMPHETAMINE TEST2Cleared 510(K)
- K970724QUICKPAC II ONE STEP METHAMPHETAMINE TEST2Cleared 510(K)
- K970265ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST2Cleared 510(K)
- K962411ONTRAK TESTCUP AMPHETAMINES2Cleared 510(K)
- K955934TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/930002Cleared 510(K)
- K955935TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS2Cleared 510(K)
- K953115AXSYM AMPHETAMINE/METHAMPHETAMINE II2Cleared 510(K)
- K935573AMPHETAMINES MICRO-PLATE EIA2Cleared 510(K)
- K951154CEDIA DAU AMPHETAMINES ASSAY2Cleared 510(K)
- K942836FINGERPRINT-DOA2Cleared 510(K)
- K945610ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP2Cleared 510(K)
- K950135URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE2Cleared 510(K)
- K943439ABUSIGN DOA42Cleared 510(K)
- K935352EMIT(R) IIC AMPHETAMINE ASSAY2Cleared 510(K)
- K944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS2Cleared 510(K)
- K943993CEDIA DAU AMPHETAMINES ASSAY2Cleared 510(K)
- K935052MICROLINE SCREEN FOR AMPHETAMINE2Cleared 510(K)
- K941372CEDIA DAU AMPHETAMINES ASSAY2Cleared 510(K)
- K935042ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT2Cleared 510(K)
- K934891AMPHETAMINES EIA ASSAY MODIFICATION2Cleared 510(K)
- K932304MICRO EIA FOR AMPHETAMINE METABOLITES2Cleared 510(K)
- K934693AMPHETAMINE TEST SYSTEM2Cleared 510(K)
- K933052ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED2Cleared 510(K)
- K931498SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY2Cleared 510(K)
- K930690STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA2Cleared 510(K)
- K924476THE TRIAGE II2Cleared 510(K)
- K921998ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED2Cleared 510(K)
- K921554AMPHETAMINES EIA TEST2Cleared 510(K)
- K920018ACCUSCREEN ASSAY2Cleared 510(K)
- K920507EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY2Cleared 510(K)
- K913738IL TEST(TM) AMPHETAMINE2Cleared 510(K)
- K914146BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE2Cleared 510(K)
- K912758ABUSCREEN ONLINE FOR AMPHETAMINES2Cleared 510(K)
- K910658ABUSCREEN ONTRAK FOR METHAMPHETAMINE2Cleared 510(K)
- K910278ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)2Cleared 510(K)
- K910739TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)2Cleared 510(K)
- K910738TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)2Cleared 510(K)
- K910756ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)2Cleared 510(K)
- K905700EZ-SCREEN: AMPHETAMINES2Cleared 510(K)
- K903993MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT2Cleared 510(K)
- K904115HYCOR ACCUPINCH METHAMPHETAMINE TEST2Cleared 510(K)
- K904451MILENIA (TM) METHAMPHETAMINE2Cleared 510(K)
- K903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY2Cleared 510(K)
- K902979MILENIA (TM) AMPHETAMINE2Cleared 510(K)
- K900995EMIT D.A.U. AMPHETAMINE CLASS ASSAY2Cleared 510(K)
- K900143ABUSCREEN FP FOR METHAMPHETAMINE2Cleared 510(K)
- K895210LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II2Cleared 510(K)
- K890692ADX AMPHETAMINE/METHAMPHEAMINE2Cleared 510(K)
- K894465ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE2Cleared 510(K)
- K894404EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE2Cleared 510(K)
- K890886ABUSCREEN FP FOR AMPHETAMINE2Cleared 510(K)
- K883707TDX AMPHETAMINE/METHAMPHETAMINE II2Cleared 510(K)
- K884022EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE2Cleared 510(K)
- K882589EMIT HVA AMPHETAMINE ASSAY2Cleared 510(K)
- K874770TDX (R) AMPHETAMINE CLASS2Cleared 510(K)
- K880013REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.2Cleared 510(K)
- K874836ABUSCREEN(R) EIA AMPHETAMINE2Cleared 510(K)
- K874486REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.2Cleared 510(K)
- K874274REVISED LABELING FOR AMPHETAMINE TEST KIT2Cleared 510(K)
- K874273REVISED LABELING FOR AMPHETAMINE TEST KIT2Cleared 510(K)
- K874080REVISED LABELING FOR SYVA AMPHETAMINE ASSAY2Cleared 510(K)
- K873755LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY2Cleared 510(K)
- K873622ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH2Cleared 510(K)
- K871696DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD52Cleared 510(K)
- K853879TDX AMPHETAMINE METHAMPHETAMINE2Cleared 510(K)
- K842674EMIT D.A.U. AMPHETAMINE ASSAY2Cleared 510(K)
- K843458EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT2Cleared 510(K)
- K833579MODIF. OF EMIT URINE AMPHETAMINE2Cleared 510(K)
- K802623EMIT-STM AMPHETAMINE ASSAY2Cleared 510(K)
- K760936EMIT AMPHETAMINE CONFIRMATION REAGENT2Cleared 510(K)
- K760196ASSAY, AMPHET. NDC#11711-0127-1 COULTER2Cleared 510(K)
- DLATest Reagents For Methyl Alcohol2Product Code
- DLBRadioimmunoassay, Lsd (125-I)2Product Code
- DLDThin Layer Chromatography, Codeine2Product Code
- DLEReagents, Test, Bromides2Product Code
- DLFEnzyme Immunoassay, Ethosuximide2Product Code
- DLHGas Chromatography, Alcohol2Product Code
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase1Product Code
- DLJCalibrators, Drug Specific2Product Code
- DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)2Product Code
- DLPRadioimmunoassay, Diphenylhydantoin2Product Code
- DLRHemagglutination Inhibition, Morphine2Product Code
- DLSGas Chromatograph, Alcohol (Dedicated Instruments)2Product Code
- DLTHemagglutination, Opiates2Product Code
- DLXHemagglutination Inhibition, Barbiturate2Product Code
- DLZEnzyme Immunoassay, Phenobarbital2Product Code
- DMBGas Chromatography, Methadone2Product Code
- DMFGas Liquid Chromatography, Barbiturate2Product Code
- DMIPotassium Dichromate Specific Reagent For Alcohol2Product Code
- DMJTest Reagents For Ethyl Alcohol2Product Code
- DMKLead, Protoporphyrin, Fluorometric2Product Code
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method2Product Code
- DMNThin Layer Chromatography, Cocaine2Product Code
- DMPDigoxin Control Serum, Ria1Product Code
- DMQGas Chromatography, Primidone2Product Code
- DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase1Product Code
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet2Product Code
- DMXLiquid Chromatography, Salicylate2Product Code
- DMYGas Chromatography, Morphine2Product Code
- DNARadioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody2Product Code
- DNCStrip, Paper, Salicylate2Product Code
- DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DNEAtomic Absorption, Antimony1Product Code
- DNFLiquid Chromatography, Ethosuximide2Product Code
- DNGFree Radical, Benzoylecgnonine2Product Code
- DNILiquid Chromatography, Amphetamine2Product Code
- DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.2Product Code
- DNKThin Layer Chromatography, Morphine2Product Code
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.2Product Code
- DNNCalibrators, Ethyl Alcohol2Product Code
- DNOHemagglutination Inhibition, Gentamicin2Product Code
- DNPThin Layer Chromatography, Ethosuximide2Product Code
- DNQRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.2Product Code
- DNSRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.2Product Code
- DNTLiquid Chromatography, Methadone2Product Code
- DNWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DNXLead, Protoporphyrin Zinc Method, Fluorometric2Product Code
- DNZAtomic Absorption, Arsenic1Product Code
- DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.2Product Code
- DOBRadioimmunoassay, Digitoxin (3-H)2Product Code
- DODGas Chromatography, Amphetamine2Product Code
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DOFLead, Atomic Absorption2Product Code
- DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol2Product Code
- DOHElectrometry, Cholinesterase1Product Code
- DOJPotassium Dichromate, Alcohol2Product Code
- DOKFree Radical Assay, Morphine2Product Code
- DOLFree Radical Assay, Lsd2Product Code
- DOMThin Layer Chromatography, Benzoylecgnonine2Product Code
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DOOLiquid Chromatography, Phenobarbital2Product Code
- DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.2Product Code
- DOSThin Layer Chromatography, Primidone2Product Code
- DOWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube2Product Code
- DOXFluorometer, Lead (Dedicated Instruments)2Product Code
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.2Product Code
- DOZLiquid Chromatography, Diphenylhydantoin2Product Code
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.2Product Code
- DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DPEThin Layer Chromatography, Diphenylhydantoin2Product Code
- DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPHMercury, Atomic Absorption1Product Code
- DPIRadioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.2Product Code
- DPKLiquid Chromatography, Morphine2Product Code
- DPLRadioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPNThin Layer Chromatography, Propoxyphene2Product Code
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPPFree Radical Assay, Methadone2Product Code
- DPQLiquid Chromatography, Primidone2Product Code
- JIHFlame Photometry, Lithium2Product Code
- JIIAtomic Absorption, Lithium2Product Code
- JKQGold Chloride (Colorimetric), Bromide2Product Code
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1Product Code
- JKTGas Chromatograph, Carbon-Monoxide1Product Code
- JXMEnzyme Immunoassay, Benzodiazepine2Product Code
- JXNEnzyme Immunoassay, Propoxyphene2Product Code
- JXOEnzyme Immunoassay, Cocaine2Product Code
- KJIRadioimmunoassay, Kanamycin2Product Code
- KLBRadioimmunoassay, Tobramycin2Product Code
- KLNRadioimmunoassay, Cocaine Metabolite2Product Code
- KLOEnzymatic Radiochemical Assay, Gentamicin2Product Code
- KLPAmikacin Serum Assay2Product Code
- KLQRadioimmunoassay, Amikacin2Product Code
- KLREnzyme Immunoassay, Lidocaine2Product Code
- KLSEnzyme Immunoassay, Theophylline2Product Code
- KLTEnzyme Immunoassay, Carbamazepine2Product Code
- KXSRadioimmunoassay, Methaqualone2Product Code
- KXTEnzyme Immunoassay, Digoxin2Product Code
- KZTKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin2Product Code
- KZWKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin2Product Code
- KZXKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin2Product Code
- KZYHigh Pressure Liquid Chromatography, Barbiturate2Product Code
- KZZGas Chromatography, Benzodiazepine2Product Code
- LAAHigh Pressure Liquid Chromatography, Benzodiazepine2Product Code
- LABThin Layer Chromatography, Benzodiazepine2Product Code
- LACHigh Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites2Product Code
- LADGas Chromatography, Codeine2Product Code
- LAEHigh Pressure Liquid Chromatography, Codeine2Product Code
- LAFGas Chromatography, Methamphetamine2Product Code
- LAGHigh Pressure Liquid Chromatography, Methamphetamine2Product Code
- LAHHigh Pressure Liquid Chromatography, Opiates2Product Code
- LAIThin Layer Chromatography, Opiates2Product Code
- LAJGas Chromatography, Propoxyphene2Product Code
- LAKHigh Pressure Liquid Chromatography, Propoxyphene2Product Code
- LALEas Chromatography, Quinine1Product Code
- LAMHigh Pressure Liquid Chromatography, Quinine1Product Code
- LANEnzyme Immunoassay, N-Acetylprocainamide2Product Code
- LAREnzyme Immunoassay, Procainamide2Product Code
- LASDrug Specific Control Materials1Product Code
- LATRadioimmunoassay, Cannabinoid(S)2Product Code
- LAWTheophylline Control Materials1Product Code
- LAXLidocaine Control Materials1Product Code
- LAYMethotrexate Control Materials1Product Code
- LAZN-Acetylprocainamide Control Materials1Product Code
- LBAProcainamide Control Materials1Product Code
- LBZEnzyme Immunoassay, Quinidine2Product Code
- LCARadioimmunoassay, Theophylline2Product Code
- LCDEnzyme Immunoassay, Gentamicin2Product Code
- LCERadioimmunoassay, Netilmicin (I-125)2Product Code
- LCQFluorescent Immunoassay Gentamicin2Product Code
- LCRFluorescent Immunoassay, Tobramycin2Product Code
- LCSRadioimmunoassay, Digoxin (125-I)2Product Code
- LCTRadioimmunoassay, Digoxin (3-H)2Product Code
- LCWRadioimmunoassay, Digitoxin (125-I)2Product Code
- LCYU.V. Spectrometry, Theophylline2Product Code
- LCZU.V. Spectrometry, Primidone2Product Code
- LDAU.V. Spectrometry, Phenobarbital2Product Code
- LDBU.V. Spectrometry, Carbamazepine2Product Code
- LDCU.V. Spectrometry, Diphenylhydantoin2Product Code
- LDJEnzyme Immunoassay, Cannabinoids2Product Code
- LDNEnzymatic Radiochemical Assay, Amikacin2Product Code
- LDOEnzymatic Radiochemical Assay, Tobramycin2Product Code
- LDPColorimetry, Acetaminophen2Product Code
- LEGEnzyme Immunoassay, Valproic Acid2Product Code
- LEHRadioimmunoassay, Vancomycin2Product Code
- LERFluorescent Immunoassay, Theophylline2Product Code
- LESFluorescent Immunoassay, Diphenylhydantoin2Product Code
- LETFluorescent Immunoassay, Phenobarbital2Product Code
- LEWThin Layer Chromatography, Theophylline2Product Code
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs2Product Code
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs2Product Code
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs2Product Code
- LFMEnzyme Immunoassay, Digitoxin2Product Code
- LFNNephelometric Inhibition Immunoassay, Phenobarbital2Product Code
- LFONephelometric Inhibition Immunoassay, Diphenylhydantoin2Product Code
- LFTFluorescent Immunoassay, Primidone2Product Code
- LFWFluorescence Polarization Immunoassay, Tobramycin2Product Code
- LGIFluorescence Polarization Immunoassay, Carbamazepine2Product Code
- LGJFluorescence Polarization Immunoassay, Amibacin2Product Code
- LGQFluorescence Polarization Immunoassay, Phenobarbital2Product Code
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)2Product Code
- LGSFluorescence Polarization Immunoassay, Theophylline2Product Code
- LPXRadioceptor Assay, Neuroleptic Drugs2Product Code
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites1Product Code
- MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs2Product Code
- MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)2Product Code
- MRSTest System, Nicotine, Cotinine, Metabolites1Product Code
- MSLSystem, Test, Topiramatee2Product Code
- NDWAssay, Porphyrin, Spectrophotometry, Lithium2Product Code
- NFTTest, Amphetamine, Over The Counter2Product Code
- NFVTest, Benzodiazepine, Over The Counter2Product Code
- NFWTest, Cannabinoid, Over The Counter2Product Code
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter2Product Code
- NGGTest, Methamphetamine, Over The Counter2Product Code
- NGITest, Morphine, Over The Counter2Product Code
- NGLTest, Opiates, Over The Counter2Product Code
- NRPSirolimus Test System2Product Code
- NTIDrug Metabolizing Enzyme Genotyping Systems2Product Code
- NWMImmunoassay, Anti-Seizure Drug2Product Code
- OAVMycophenolic Acid Test System2Product Code
- ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System2Product Code
- OIWSoftware, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types2Product Code
- ORABreast Milk-Alcohol Test System2Product Code
- ORHLamotrigine Assay2Product Code
- ORILevetiracetam Assay2Product Code
- OTFGabapentin Assay2Product Code
- OUFEverolimus Immunoassay2Product Code
- PDYOrganophosphate Test System2Product Code
- POXEnzyme Immunoassay, Oxcarbazepine Metabolite2Product Code
- PTGTest, Methadone, Over The Counter2Product Code
- PTHTest, Barbiturate, Over The Counter2Product Code
- PUJVoriconazole Test System2Product Code
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt2Product Code
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt2Product Code
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt2Product Code
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt2Product Code
- PVBTest, Codeine, Employment And Insurance Testing, Exempt2Product Code
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt2Product Code
- PVETest, Methadone, Employment And Insurance Testing, Exempt2Product Code
- PVFTest, Methaqualone, Employment And Insurance Testing, Exempt2Product Code
- PVGTest, Morphine, Employment And Insurance Testing, Exempt2Product Code
- PVHTest, Opiates, Employment And Insurance Testing, Exempt2Product Code
- PVITest, Propoxyphene, Employment And Insurance Testing, Exempt2Product Code
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt2Product Code
- PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt2Product Code
- QAWTest, Tricyclic Antidepressants, Over The Counter2Product Code
- QBFTest, Propoxyphene, Over The Counter2Product Code
- QBKMeprobamate Test System2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161251
- 510(k) Type
- Traditional
- Applicant
- Hangzhou Clongene Biotech Co., Ltd
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2016
- Days to Decision
- 119 days
- Submission Type
- Summary