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
- K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series1Cleared 510(K)
- K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ1Cleared 510(K)
- K132174MULTICHEM WBT1Cleared 510(K)
- K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL1Cleared 510(K)
- K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)1Cleared 510(K)
- K120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK1Cleared 510(K)
- K103656THERMO SCIENTIFIC MAS R DOA TOTAL1Cleared 510(K)
- K093577LIQUICHEK OPIATE CONTROL1Cleared 510(K)
- K080085MAS TOX CONTROL1Cleared 510(K)
- K080183CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 5001Cleared 510(K)
- K072721LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC1Cleared 510(K)
- K063398ESA LEADCARE II LEAD CONTROL1Cleared 510(K)
- K062191DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC5161Cleared 510(K)
- K060788TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 944141Cleared 510(K)
- K060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL1Cleared 510(K)
- K052053LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK1Cleared 510(K)
- K050682LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)1Cleared 510(K)
- K050037TRIAGE TOX DRUG SCREEN CONTROLS1Cleared 510(K)
- K042865LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)1Cleared 510(K)
- K041666DC-ACETA/SAL CONTROLS1Cleared 510(K)
- K041561LIQUICHEK WHOLE BLOOD VOLATILES CONTROL1Cleared 510(K)
- K040758MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT1Cleared 510(K)
- K033924LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)1Cleared 510(K)
- K033404LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)1Cleared 510(K)
- K033366LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 4551Cleared 510(K)
- K032826MAS PAR TDM1Cleared 510(K)
- K022707LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 4391Cleared 510(K)
- K021414LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 4671Cleared 510(K)
- K021415LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 4691Cleared 510(K)
- K021411LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 4631Cleared 510(K)
- K021384LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,4441Cleared 510(K)
- K012999TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #940011Cleared 510(K)
- K013002TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #940021Cleared 510(K)
- K012907LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL1Cleared 510(K)
- K012741LIQUICHEK TDM CONTROL1Cleared 510(K)
- K012319RANDOX HUMAN ASSSAYED DRUG CONTROL1Cleared 510(K)
- K992395URINE DRUG SCREENING CONTROL1Cleared 510(K)
- K990377ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV1Cleared 510(K)
- K983709SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 11Cleared 510(K)
- K983387ONTRAK TESTCUP AND TESTSTIK CONTROLS1Cleared 510(K)
- K983127OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G31Cleared 510(K)
- K982649VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III1Cleared 510(K)
- K982217AC/AD LINEARITY VERIFIERS1Cleared 510(K)
- K982024OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 31Cleared 510(K)
- K981590LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON1Cleared 510(K)
- K980871LYPHOCHEK WHOLE BLOOD CONTROL1Cleared 510(K)
- K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S1Cleared 510(K)
- K972819VIGIL TDM CONTROLS1Cleared 510(K)
- K971060PRECINORM TDM CONTROLS1Cleared 510(K)
- K972174LYPHOCHEK REMEDI CONTROL1Cleared 510(K)
- K971691LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S31Cleared 510(K)
- K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL1Cleared 510(K)
- K971058DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)1Cleared 510(K)
- K970666LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL1Cleared 510(K)
- K964771DE-TOX CONTROL 1 AND DE-TOX CONTROL 191Cleared 510(K)
- K965157CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 11Cleared 510(K)
- K964422ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL1Cleared 510(K)
- K962165COBAS-FP TDM CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K961724U-DOA CONTROLS1Cleared 510(K)
- K960244DOCUMENT TDM ULTRA ASSAYED CONTROL1Cleared 510(K)
- K955153LYPHOCHEK BENZO/TCA CONTROL-SET B1Cleared 510(K)
- K955155DOCUMENT TDM ULTRA UNASSAYED CONTROL1Cleared 510(K)
- K954799ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL1Cleared 510(K)
- K954291OPUS TDM CONTROLS1Cleared 510(K)
- K954322TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL1Cleared 510(K)
- K953845ABUSCREEN ONLINE DRUG FREE URINE1Cleared 510(K)
- K953739ABUSCREEN ONLINE CONTROLS1Cleared 510(K)
- K952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL1Cleared 510(K)
- K951817ELI URINE CONTROLS1Cleared 510(K)
- K952056IMMUNOASSAY DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K951135MULTI-DRUG CONTROL SET1Cleared 510(K)
- K950138DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K943999ABUSCREEN ONTRAK POSITIVE CONTROL1Cleared 510(K)
- K945194ABUSCREEN ONLINE CONTROLS1Cleared 510(K)
- K943422TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL1Cleared 510(K)
- K942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED1Cleared 510(K)
- K942257DOA-PLUS, DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K942041NIDA-5/RT, DRUG OF ABUSE CONTROLS1Cleared 510(K)
- K942552THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED1Cleared 510(K)
- K942114ROCHE TDM CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K940433DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G41Cleared 510(K)
- K936166CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS1Cleared 510(K)
- K934498DOA LIQUID DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K934650CEDIA DAU CONTROLS1Cleared 510(K)
- K935285DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K935230EMIT IIC NEGATIVE CONTROL, CONTROL I AND II1Cleared 510(K)
- K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS1Cleared 510(K)
- K932549ABUSCREEN ONLINE LOW-CUTOFF CONTROLS1Cleared 510(K)
- K931125ABUSCREEN ONLINE CONTROL1Cleared 510(K)
- K932643LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL1Cleared 510(K)
- K931105PROCHECK(TM) BLIND PERFORMANCE SPECIMENS1Cleared 510(K)
- K930269COBAS-FP TDM CONTROLS1Cleared 510(K)
- K925586DETECTABUSE(TM)1Cleared 510(K)
- K920477DRUG OF ABUSE URINE CONTROL1Cleared 510(K)
- K914170LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)1Cleared 510(K)
- K914806ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL1Cleared 510(K)
- K913309TDM I LINEARITY TEST SET1Cleared 510(K)
- K913650DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL1Cleared 510(K)
- K911724ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION1Cleared 510(K)
- K911168ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III1Cleared 510(K)
- K911167ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II1Cleared 510(K)
- K910930ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.11Cleared 510(K)
- K905457CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL1Cleared 510(K)
- K910333CHALLENGE (TM) LIQ THERA DRUG CONTROLS1Cleared 510(K)
- K904905DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS1Cleared 510(K)
- K903909BLIND CONTROLS FOR DRUGS OF ABUSE TESTING1Cleared 510(K)
- K903189KODATROL LIQUID CONTROL LEVELS I & II1Cleared 510(K)
- K901270LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN1Cleared 510(K)
- K901271LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM1Cleared 510(K)
- K900626ALPHA URINE SAMPLE1Cleared 510(K)
- K892380DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III1Cleared 510(K)
- K895816BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.1Cleared 510(K)
- K893682KIT- CIBA CORNING L-TDM I, II, III1Cleared 510(K)
- K893835DAU I, DAU II, DAU III AND DAU IV CONTROL URINE1Cleared 510(K)
- K890957HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:1Cleared 510(K)
- K884178DRUG CONTROL SET1Cleared 510(K)
- K890406DETECTABUSE DRUG CONTROLS1Cleared 510(K)
- K890030NEW LOW LEVEL DRUG MIXTURE CONTROL1Cleared 510(K)
- K883210EMIT (R) HVA NEGATIVE URINE1Cleared 510(K)
- K883190DADE TDM CONTROL1Cleared 510(K)
- K881944EMIT HVA CONTROL KIT1Cleared 510(K)
- K881989LYPHOCHEK URINE TOXICOLOGY CONTROL1Cleared 510(K)
- K881990LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW1Cleared 510(K)
- K881991LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE1Cleared 510(K)
- K880145LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL1Cleared 510(K)
- K880152PAR(TM) BRAND DRUG OF ABUSE CONTROLS1Cleared 510(K)
- K880512DRUG MIXTURE CONTROL IN URINE1Cleared 510(K)
- K880445LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW1Cleared 510(K)
- K880444LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE1Cleared 510(K)
- K874757STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III1Cleared 510(K)
- K873183TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS1Cleared 510(K)
- K873539ACA URINE DRUGS OF ABUSE CONTROL1Cleared 510(K)
- K873037CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL1Cleared 510(K)
- K873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL1Cleared 510(K)
- K871694HYPERFORMANCE CONTROLS (HP-CONTROLS)1Cleared 510(K)
- K871788LIQUID TDM CONTROLS1Cleared 510(K)
- K870586TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG1Cleared 510(K)
- K863388QUANTIMETRIX DRUG FREE SERUM CONTROL1Cleared 510(K)
- K862817V-TREND QC TDM CONTROL SERUM 1,2,3.1Cleared 510(K)
- K861970LYPHOCHEK URINE TOXICOLOGY CONTROL1Cleared 510(K)
- K860919THERACHEM, TDC THERAPEUTIC DRUG CONTROLS1Cleared 510(K)
- K860097THERAPEUTIC DRUG (TDM) CALIBRATOR1Cleared 510(K)
- K853933QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL1Cleared 510(K)
- K852414LYPHOCHEK DRUG FREE SERUM(HUMAN)1Cleared 510(K)
- K844946EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL1Cleared 510(K)
- K844945EMIT IMIPRAMINE/DESIPRAMINE CONTROL1Cleared 510(K)
- K843913COBAS FP TDM CONTROLS1Cleared 510(K)
- K843818HUMAN SERUM ANTICONVULSANT DRUG CONTROL1Cleared 510(K)
- K843679HUMAN SERUM CARDIOACTIVE DRUG CONTROL1Cleared 510(K)
- K843508EMIT 700 CONTROL SET B1Cleared 510(K)
- K843161EMIT 700 CONTROL SET A1Cleared 510(K)
- K841439COMA TOXICOLOGY CONTROL1Cleared 510(K)
- K840921THERACHEM TDC THERAPEUTIC DRUG CONTROL1Cleared 510(K)
- K834259LIQUI-URA TOXIC URINE CONTROL1Cleared 510(K)
- K833794LYPHOCHEK THERAPEUTIC DRUG CONTROL1Cleared 510(K)
- K831736TRICYCLIC ANTIDEPRESSANTS1Cleared 510(K)
- K831741FLURAZEPAM TOXICOLOGY CONTROL1Cleared 510(K)
- K831734AMOXAPINE 8-HYDRO-XYAMOXAPINE1Cleared 510(K)
- K831737TRICYCLIC ANTIDEPRESSNATS VI1Cleared 510(K)
- K831740DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1Cleared 510(K)
- K831500TRI-LEVEL TDM CONTROL & I II III1Cleared 510(K)
- K831278LIQUI-SERA ANTICONVULSANTS CONTROLS1Cleared 510(K)
- K830518EMIT-ST PHOTOMETER & DILUTER VERIFICA1Cleared 510(K)
- K830494CONTOX DRUG SCREEN CONTROL1Cleared 510(K)
- K830492CONTOX DURG CONTROL1Cleared 510(K)
- K830234CONTOX HEAVYMETALS CONTROL1Cleared 510(K)
- K823746ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG1Cleared 510(K)
- K822777THERAPEUTIC DRUG CONTROL1Cleared 510(K)
- K821975ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX1Cleared 510(K)
- K821973Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.1Cleared 510(K)
- K821950Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED1Cleared 510(K)
- K820296STRATUS TDM CONTROL, LEVELS I,II,III1Cleared 510(K)
- K820468PROFILE GENERAL SET ASSAYED SERUM CONTR1Cleared 510(K)
- K820462EMIT-ST URINE CONTROLS SET A #3A3491Cleared 510(K)
- K820191CONTROL SET1Cleared 510(K)
- K813349BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL1Cleared 510(K)
- K812950QAC CONTROL1Cleared 510(K)
- K811756THERAPEUTIC DRUG CONTROL1Cleared 510(K)
- K811809ANTI-ARRHYTHMIC CONTROL LEVELS I & II1Cleared 510(K)
- K811811TDM ANTI-CONVULSANT CONTROL LEVELS I-II1Cleared 510(K)
- K811618EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL1Cleared 510(K)
- K810504THERACHEM ANTI CONVULSANTA THEOPHYLLINE1Cleared 510(K)
- K810468EMIT-ST SERUM CONTROLS1Cleared 510(K)
- K810235ACETAMINOPHEN/SALICYLATE CONTROL1Cleared 510(K)
- K810078Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S1Cleared 510(K)
- K810077OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.1Cleared 510(K)
- K803097DIGOXIN & PHENYTOIN CONTROL SERA1Cleared 510(K)
- K803039PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.1Cleared 510(K)
- K803036PROFILE CARDIAC SET ASSAYED SERUM CONTR.1Cleared 510(K)
- K802854BECKMAN ICS DRUG CONTROL SERA1Cleared 510(K)
- K802672CARDIOACTIVE DRUGS CONTROL1Cleared 510(K)
- K802278IN VITRO DIAGNOSTIC STANDARDS1Cleared 510(K)
- K800888TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1Cleared 510(K)
- K800883CARDIACS I TOXICOLOGY CONTROL1Cleared 510(K)
- K800889TRICYCLIC ANTIDEPRESSANT II TX CONTROL1Cleared 510(K)
- K800887HYPNOTICS PLUS SALICYLATE TX CONTROL1Cleared 510(K)
- K800886HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1Cleared 510(K)
- K800885BARBITURATES TOXICOLOGY CONTROL1Cleared 510(K)
- K800884CARDIACS II TOXICOLOGY CONTROL1Cleared 510(K)
- K800882ANTICONVULSANTS TOXICOLOGY CONTROL1Cleared 510(K)
- K782128THERA CHEM1Cleared 510(K)
- K780960SERUM, CONTROL, DRUGS, ANTIARRYTHMIC1Cleared 510(K)
- 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
- 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
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K990377
- 510(k) Type
- Traditional
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/1999
- Days to Decision
- 18 days
- Submission Type
- Summary