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
- K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2Cleared 510(K)
- K211973DRI Cocaine Metabolite Assay2Cleared 510(K)
- K191638Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2Cleared 510(K)
- K181499DRI Cocaine Metabolite Assay2Cleared 510(K)
- K170293Emit II Plus Cocaine Metabolite Assay2Cleared 510(K)
- K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)2Cleared 510(K)
- K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup2Cleared 510(K)
- K152232Quest Diagnostics HairCheck-DT (Cocaine)2Cleared 510(K)
- K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)2Cleared 510(K)
- K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana2Cleared 510(K)
- K142129RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET2Cleared 510(K)
- K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set2Cleared 510(K)
- K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test2Cleared 510(K)
- K141647HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)2Cleared 510(K)
- K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES2Cleared 510(K)
- K131754WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)2Cleared 510(K)
- K121166WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL2Cleared 510(K)
- K113751RANDOX COCAINE METABOLITE2Cleared 510(K)
- K103227ORATECT ORAL FLUID DRUG SCREEN DEVICES2Cleared 510(K)
- K103295QUICKSCREEN COCAINE 150 SCREENING TEST2Cleared 510(K)
- K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES2Cleared 510(K)
- K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)2Cleared 510(K)
- K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS2Cleared 510(K)
- K112071WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P2Cleared 510(K)
- K101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY2Cleared 510(K)
- K101160ROCHE ORAL FLUID COCAINE2Cleared 510(K)
- K080436RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-00522Cleared 510(K)
- K062929QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA2Cleared 510(K)
- K062123VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV2Cleared 510(K)
- K053422RAPIDONE-COCAINE-150 TEST2Cleared 510(K)
- K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET0010002Cleared 510(K)
- K050945ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS2Cleared 510(K)
- K051578IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS2Cleared 510(K)
- K050465IMMUNALYSIS COCAINE ELISA FOR HAIR2Cleared 510(K)
- K050321ONTRAK TESTCARD 92Cleared 510(K)
- K033866CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)2Cleared 510(K)
- K040198LABONE COCAINE METABOLITE MICRO-PLATE EIA2Cleared 510(K)
- K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE2Cleared 510(K)
- K033713URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A2Cleared 510(K)
- K030360RANDOX EVIDENCE2Cleared 510(K)
- K023626AML HAIRCHECK-DT (COCAINE)2Cleared 510(K)
- K032057TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC2Cleared 510(K)
- K031512EMIT II PLUS COCAINE METABOLITE ASSAY2Cleared 510(K)
- K030234COZART EIA COCAINE ORAL FLIUD KIT2Cleared 510(K)
- K023489QUICKTOX MULTIPLE DRUG DIPCARD2Cleared 510(K)
- K023281ONLINE DAT II COCAINE II2Cleared 510(K)
- K023296COBAS INTEGRA ONLINE DAT II COCAINE II2Cleared 510(K)
- K022954AMEDICA DRUG SCREEN COCAINE TEST2Cleared 510(K)
- K022355QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT612Cleared 510(K)
- K014067LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC2Cleared 510(K)
- K014069LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC2Cleared 510(K)
- K020771ACON ONE STEP DRUG SCREEN TEST CARD2Cleared 510(K)
- K020763COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)2Cleared 510(K)
- K020441EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY2Cleared 510(K)
- K013004COCAINE2Cleared 510(K)
- K011814AMEDITECH IMMUTEST DRUG SCREEN COC2Cleared 510(K)
- K011962ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST2Cleared 510(K)
- K011054RADS2Cleared 510(K)
- K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE2Cleared 510(K)
- K010239COCAINE DIPSTICK TEST, MODEL D747-A2Cleared 510(K)
- K011162MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY2Cleared 510(K)
- K010967LIVESURE COCAINE SCREEN TEST2Cleared 510(K)
- K010833AT WORK DRUG TEST, MODEL 9177T AWT2Cleared 510(K)
- K010650AT HOME DRUG TEST, MODEL 9073 T2Cleared 510(K)
- K003708ADVANTAGE THC/COCAINE TEST2Cleared 510(K)
- K002264BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST2Cleared 510(K)
- K994403INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST2Cleared 510(K)
- K994398INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST2Cleared 510(K)
- K001197COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA2Cleared 510(K)
- K000467URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A2Cleared 510(K)
- K000350SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST2Cleared 510(K)
- K994165ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 11185952Cleared 510(K)
- K993988SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL2Cleared 510(K)
- K994219AT HOME DRUG TEST, MODEL 90732Cleared 510(K)
- K993485VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE2Cleared 510(K)
- K992990QUICKPAC II ONE STEP COCAINE TEST2Cleared 510(K)
- K992748DRUGCHECK X MULTIDRUG SCREENING DEVICE2Cleared 510(K)
- K991110REDI-TEST COCAINE2Cleared 510(K)
- K992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM2Cleared 510(K)
- K990822RAPIDONE - COCAINE TEST2Cleared 510(K)
- K983697MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE2Cleared 510(K)
- K982759AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U2Cleared 510(K)
- K983388ONTRAK TESTCUP-ER2Cleared 510(K)
- K983191DBEST COCAINE TEST KIT2Cleared 510(K)
- K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)2Cleared 510(K)
- K981388MICRO-STRIP FOR COCAINE METABOLITES2Cleared 510(K)
- K973986MECTEST2Cleared 510(K)
- K980153DRUG CHECK2Cleared 510(K)
- K980872RAPID DRUG SCREEN' 8 PANEL2Cleared 510(K)
- K973651STC COCAINE METABOLITE MICRO-PLATE EIA2Cleared 510(K)
- K972059QUIKPAC II ONE STEP COCAINE TEST2Cleared 510(K)
- K972384AQ ONE STEP COCAINE TEST2Cleared 510(K)
- K971926QUIKSTRIP ONE STEP COCAINE TEST2Cleared 510(K)
- K964900RAPID DRUG SCREEN2Cleared 510(K)
- K963918IMMULITE COCAINE METABOLITE2Cleared 510(K)
- K962353ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)2Cleared 510(K)
- K960187COCAINE METABOLITE EIA TEST2Cleared 510(K)
- K954496FRONTLINE COCAINE2Cleared 510(K)
- K954571ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI2Cleared 510(K)
- K952361ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC2Cleared 510(K)
- K945549ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET2Cleared 510(K)
- K945207MECTEST2Cleared 510(K)
- K951892ONE STEP URINE DRUG OF ABUSE COCAINE TEST2Cleared 510(K)
- K951289AXSYM COCAINE METABOLITE2Cleared 510(K)
- K934775STC COCAINE METABOLITE EIA2Cleared 510(K)
- K950369VISUALINE II COCAINE2Cleared 510(K)
- K945609ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC2Cleared 510(K)
- K935323EMIT IIC COCAINE METABOLITE ASSAY2Cleared 510(K)
- K945345CEDIA DAU COCAINE ASSAY2Cleared 510(K)
- K944231ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC2Cleared 510(K)
- K944087CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS2Cleared 510(K)
- K943710VERDICT COCAINE2Cleared 510(K)
- K941310CEDIA DAU COCAINE ASSAY2Cleared 510(K)
- K935904CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS2Cleared 510(K)
- K935016COCAINE METABOLITE EIA ASSAY MODIFICATION2Cleared 510(K)
- K933053ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF2Cleared 510(K)
- K930985USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-1002Cleared 510(K)
- K921834AUTOMATES COMA COCAINE METABOLITE ASSAY2Cleared 510(K)
- K915371COCAINE METABOLITE EIA TEST2Cleared 510(K)
- K914533MICRO EIA FOR COCAINE METABOLITES2Cleared 510(K)
- K914973SYVA EMIT D.A.U. COCAINE METABOLITE2Cleared 510(K)
- K911652MIRCOLINE SCREEN FOR COCAINE2Cleared 510(K)
- K902579EMIT(R) II COCAINE METABOLITE ASSAY2Cleared 510(K)
- K896781MICRO DAU COCAINE METABOLITE TEST KIT2Cleared 510(K)
- K896937HYCOR ACCUPINCH COCAINE TEST2Cleared 510(K)
- K895043COMA COCAINE METABOLITE ASSAY (EIA)2Cleared 510(K)
- K890788ADX COCAINE METABOLITE2Cleared 510(K)
- K890883ABUSCREEN FP BUFFER REAGENT2Cleared 510(K)
- K890885ABUSCREEN FP FOR COCAINE METABOLITE2Cleared 510(K)
- K883105EZ-SCREEN CANNABINOID/COCAINE2Cleared 510(K)
- K881815ABUSCREEN(R) ONTRAK(TM) FOR COCAINE2Cleared 510(K)
- K881942EMIT HVA COCAINE METABOLITE ASSAY2Cleared 510(K)
- K880009REVISED LABELING FOR ADX COCAINE METABOLITE2Cleared 510(K)
- K874487REVISED LABELING FOR TDX COCAINE METABOLITE2Cleared 510(K)
- K874271REVISED LABELING FOR COCAINE/COCAINE META. TEST2Cleared 510(K)
- K874213ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN2Cleared 510(K)
- K874201REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY2Cleared 510(K)
- K873751LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE2Cleared 510(K)
- K873752LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY2Cleared 510(K)
- K871305COCAINE METABOLITE ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K863843COCAINE METABOLITE ROCHE(R) EIA2Cleared 510(K)
- K854163TDX COCAINE METABOLITE2Cleared 510(K)
- K843556EMIT D.A.U. COCAINE ASSAY2Cleared 510(K)
- K843160EMIT 700 COCAINE METABOLITE ASSAY2Cleared 510(K)
- K834549EMIT ST. URINE COCAINE METABOLITE2Cleared 510(K)
- 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
RANDOX EVIDENCE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K030360
- 510(k) Type
- Traditional
- Applicant
- RANDOX LABORATORIES, LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/23/2003
- Days to Decision
- 323 days
- Submission Type
- Statement