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
- 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
- K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 502Cleared 510(K)
- K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)2Cleared 510(K)
- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT2Cleared 510(K)
- K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 202Cleared 510(K)
- K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test2Cleared 510(K)
- K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana2Cleared 510(K)
- K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set2Cleared 510(K)
- K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls2Cleared 510(K)
- K142408FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)2Cleared 510(K)
- K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST2Cleared 510(K)
- K132096RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR2Cleared 510(K)
- K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE2Cleared 510(K)
- K122633TOXCUP DRUG SCREEN CUP2Cleared 510(K)
- K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)2Cleared 510(K)
- K121557WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST2Cleared 510(K)
- K111929PSYCHEMEDICS CANNABINOIDS EIA2Cleared 510(K)
- K102428WUNDER TEST2Cleared 510(K)
- K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL2Cleared 510(K)
- K110182CANNABINOIDS URINE TEST2Cleared 510(K)
- K101744THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY2Cleared 510(K)
- K092269CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET2Cleared 510(K)
- K082977BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP2Cleared 510(K)
- K080467BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,2Cleared 510(K)
- K080872AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ2Cleared 510(K)
- K063164VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV2Cleared 510(K)
- K061556AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C10202Cleared 510(K)
- K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI0010002Cleared 510(K)
- K050936ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE2Cleared 510(K)
- K050878ON CALL MULTI-DRUG HOME TEST CUP2Cleared 510(K)
- K050594NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE2Cleared 510(K)
- K050050ON CALL MULTI-DRUG HOME TEST2Cleared 510(K)
- K041142RANDOX CANNABINOIDS ASSSAY2Cleared 510(K)
- K041221ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY2Cleared 510(K)
- K040257QUEST DIAGNOSTICS HAIRCHECK-DT (THC)2Cleared 510(K)
- K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST2Cleared 510(K)
- K040629ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE2Cleared 510(K)
- K023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI2Cleared 510(K)
- K030213ONLINE DAT II CANNABINOIDS II2Cleared 510(K)
- K022955AMEDICA DRUG SCREEN THC TEST2Cleared 510(K)
- K021887CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 00712Cleared 510(K)
- K014066LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC2Cleared 510(K)
- K014193LIFESIGN DOA 4 (THC/OPI/COC/MET)2Cleared 510(K)
- K013247CANNABINOIDS2Cleared 510(K)
- K012390NO STEP ON SITE DEUG TEST CUP2Cleared 510(K)
- K011813AMEDITECH IMMUTEST DRUG SCREEN THC2Cleared 510(K)
- K012541MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET2Cleared 510(K)
- K010921ADVANTAGE MARIJUANA (THC) HOME DRUG TEST2Cleared 510(K)
- K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N2292Cleared 510(K)
- K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)2Cleared 510(K)
- K010138PROFILE II ER2Cleared 510(K)
- K010001LIVESURE THC SCREEN TEST2Cleared 510(K)
- K002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I2Cleared 510(K)
- K002263BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST2Cleared 510(K)
- K001126PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST2Cleared 510(K)
- K994138FIRST CHECK HOME DRUG TEST PANEL 32Cleared 510(K)
- K994139FIRST CHECK HOME DRUG TEST PANEL 22Cleared 510(K)
- K993663FIRST CHECK HOME DRUG TEST (THC)2Cleared 510(K)
- K994410INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST2Cleared 510(K)
- K001567ADVANTAGE THC TEST2Cleared 510(K)
- K994164ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 11185792Cleared 510(K)
- K000461URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A2Cleared 510(K)
- K000131QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT042Cleared 510(K)
- K993961RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)2Cleared 510(K)
- K993984SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL2Cleared 510(K)
- K994220AT HOME DRUG TEST, MODEL 90782Cleared 510(K)
- K992949SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST2Cleared 510(K)
- K993796RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE2Cleared 510(K)
- K991516MICRO-STRIP FOR MARIJUANA METABOLITES2Cleared 510(K)
- K990818RAPIDONE - MARIJUANA TEST2Cleared 510(K)
- K990870REDI-TEST THC2Cleared 510(K)
- K983701MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS2Cleared 510(K)
- K983188DBEST TETRAHYDROCANNABINOL TEST KIT2Cleared 510(K)
- K973154UBI MAGIWEL MARIJUANA METABOLITES2Cleared 510(K)
- K980836GENIE CUP INTEGRATED SCREENING DEVICE2Cleared 510(K)
- K981585ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)2Cleared 510(K)
- K981584ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)2Cleared 510(K)
- K973750STC CANNABINOIDS MICRO-PLATE EIA2Cleared 510(K)
- K973122QUICKSCREEN ONE STEP THC SCREENING TEST2Cleared 510(K)
- P950040DR. BROWN'S HOME DRUG TESTING KIT2PMA Approval
- K970548ONE STEP MARIJUANA CARD TEST2Cleared 510(K)
- K971841BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST2Cleared 510(K)
- K963916IMMULITE CANNABINOIDS2Cleared 510(K)
- K963654QUIKSTRIP ONESTEP MARIJUANA (THC) TEST2Cleared 510(K)
- P950040DR. BROWN'S HOME DRUG TESTING KIT2PMA Approval
- K963207QUICKPAC II ONE STEP MARIJUANA (THC) TEST2Cleared 510(K)
- P950040DR. BROWN'S HOME DRUG TESTING KIT2PMA Approval
- P950040DR. BROWN'S HOME DRUG TESTING KIT2PMA Approval
- K963606VISUALINE COMBO V (COCAINE/THC) TEST2Cleared 510(K)
- K963516VERDICT THC2Cleared 510(K)
- K951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)2Cleared 510(K)
- K955677SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT2Cleared 510(K)
- K954497FRONTLINE CANNABIS2Cleared 510(K)
- K950445VISUALINE II CANNABINOIDS (THC)2Cleared 510(K)
- K950181URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE2Cleared 510(K)
- K945550ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC2Cleared 510(K)
- K940158EMIT IIC CANNABINOID ASSAY2Cleared 510(K)
- K944086CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS2Cleared 510(K)
- K944088CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS2Cleared 510(K)
- K943998CANNABINOID EIA ASSAY2Cleared 510(K)
- K944562MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION2Cleared 510(K)
- K942337CEDIA DAU MULTI-LEVEL THC ASSAY2Cleared 510(K)
- K940912USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-5002Cleared 510(K)
- K940649CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT2Cleared 510(K)
- K935591CEDIA DAU MULTI-LEVEL THC ASSAY2Cleared 510(K)
- K932716EMIT(R) THC 50/100 NG ASSAY2Cleared 510(K)
- K931598BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)2Cleared 510(K)
- K930654STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA2Cleared 510(K)
- K924815MICROPLATE CANNABINOIDS ASSAY2Cleared 510(K)
- K920418IL TEST CANNABINOID, 352822Cleared 510(K)
- K920311CANNABINOID EIA TEST2Cleared 510(K)
- K914915MICROLINE SCREEN FOR CANNABINOID2Cleared 510(K)
- K914490MICRO EIA FOR MARIJUANA METABOLITES2Cleared 510(K)
- K912757ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS2Cleared 510(K)
- K910592ABUSCREEN FP FOR CANNABINOIDS (15-50)2Cleared 510(K)
- K910893TARGET(TM) CANNABINOIDS-R TEST2Cleared 510(K)
- K910892TARGET(TM) CANNABINOIDS-V TEST2Cleared 510(K)
- K910589ABUSCREEN FP FOR CANNABINOIDS (50-100)2Cleared 510(K)
- K904571EMIT(R) II CANNABINOID 50 NG ASSAY2Cleared 510(K)
- K904568EMIT(R) II CANNABINOID 100 NG ASSAY2Cleared 510(K)
- K904570EMIT(R) II CANNABINOID 20 NG ASSAY2Cleared 510(K)
- K904856ABUSCREEN ONTRAK FOR THC2Cleared 510(K)
- K904541LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS2Cleared 510(K)
- K904635MICROZYME THC ENZYME IMMUNOASSAY TEST KIT2Cleared 510(K)
- K901568MILENIA(TM) CANNABINOIDS2Cleared 510(K)
- K901334HYCOR ACCUPINCH THC TEST2Cleared 510(K)
- K890693ADX CANNABINOIDS2Cleared 510(K)
- K874390CRACK-IT CANNABINOID SCREEN2Cleared 510(K)
- K890887ABUSCREEN FP FOR CANNABINOIDS2Cleared 510(K)
- K883731TDX CANNABINOIDS-GS2Cleared 510(K)
- K882313EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS2Cleared 510(K)
- K882819EMIT HVA CANNABINOID 100 NG ASSAY2Cleared 510(K)
- K881814ABUSCREEN(R) ONTRAK(TM) FOR THC2Cleared 510(K)
- K875219MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN2Cleared 510(K)
- K882362STAT FIX MICROWAVE IRRADIATION MEDIUM2Cleared 510(K)
- K880015REVISED LABELING FOR ADX CANNABINOIDS2Cleared 510(K)
- K875252ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH2Cleared 510(K)
- K874646TDXR DELTA-9-CANNABINOIDS2Cleared 510(K)
- K874488REVISED LABELING FOR TDX CANNABINOIDS2Cleared 510(K)
- K874269REVISED LABELING FOR CANNABINOIDS TEST KIT2Cleared 510(K)
- K872882CANNABINOID ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K874156STICKER LABEL FOR DRUGS OF ABUSE ASSAYS2Cleared 510(K)
- K874079REVISED LABELING FOR SYVA CANNABINOID ASSAYS2Cleared 510(K)
- K873753LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE2Cleared 510(K)
- K871695DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD52Cleared 510(K)
- K870197KDI QUIK TEST(TM) MARIJUANA SCREEN2Cleared 510(K)
- K870377ABUSCREEN (R) EIA CANNABINOIDS2Cleared 510(K)
- K864751TDXR CANNABINOIDS2Cleared 510(K)
- K860500EMIT D.A.U. CANNABINOID 20NG ASSAY2Cleared 510(K)
- K851373EMIT 700 CANNABINOID 20 ASSAY2Cleared 510(K)
- K843421EMIT 700 CANNABINOID ASSAY2Cleared 510(K)
- K841238EMIT ST URINE CANNABINOID ASSAY2Cleared 510(K)
- K834458EMIT D.A.U. URINE CANNABINOID ASSAY2Cleared 510(K)
- K833580MODIF. OF EMIT URINE CANNABINOID2Cleared 510(K)
- K812195EMIT-ST CANNABINOID ASSAY2Cleared 510(K)
- 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
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K082977
- 510(k) Type
- Special
- Applicant
- MK BIO, INC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/20/2009
- Days to Decision
- 318 days
- Submission Type
- Summary