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
- K252520SEFRIA™ Hydrocodone Oral Fluid2Cleared 510(K)
- K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)2Cleared 510(K)
- K251634LZI Fentanyl III Enzyme Immunoassay2Cleared 510(K)
- K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader2Cleared 510(K)
- K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard2Cleared 510(K)
- K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard2Cleared 510(K)
- K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card2Cleared 510(K)
- K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)2Cleared 510(K)
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test2Cleared 510(K)
- K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup2Cleared 510(K)
- K231752ARK Hydrocodone Assay2Cleared 510(K)
- K221550Evidence MultiSTAT DOA Urine MultiPlex2Cleared 510(K)
- K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2Cleared 510(K)
- K231007CEDIA Heroin Metabolite (6-AM) Assay2Cleared 510(K)
- K231698AllTest Fentanyl Rapid Test (Urine)2Cleared 510(K)
- K221605Emit® II Plus Buprenorphine Assay2Cleared 510(K)
- K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx2Cleared 510(K)
- K222955Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2Cleared 510(K)
- K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-112Cleared 510(K)
- K203527Immunalysis Tapentadol Urine HEIA2Cleared 510(K)
- K203564SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay2Cleared 510(K)
- K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests2Cleared 510(K)
- K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair2Cleared 510(K)
- K202007LZI Oxycodone III Enzyme Immunoassay2Cleared 510(K)
- K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card2Cleared 510(K)
- K201938LZI Fentanyl II Enzyme Immunoassay2Cleared 510(K)
- K201223LZI Tramadol Enzyme Immunoassay2Cleared 510(K)
- K200197ARK Fentanyl II Assay2Cleared 510(K)
- K192943CEDIA Heroin Metabolite (6-AM) assay2Cleared 510(K)
- K182103Psychemedics Microplate EIA for Fentanyl in Hair2Cleared 510(K)
- K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card2Cleared 510(K)
- K182280ARK Tramadol Assay2Cleared 510(K)
- K181159LZI Fentanyl Enzyme Immunoassay2Cleared 510(K)
- K180427ARK Fentanyl Assay2Cleared 510(K)
- K172416Synermed Opiate Enzyme Immunoassay2Cleared 510(K)
- K173195DRI Hydrocodone Assay2Cleared 510(K)
- K173183CEDIA Heroin Metabolite (6-AM) Assay2Cleared 510(K)
- K172910Emit II Plus Oxycodone Assay2Cleared 510(K)
- K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators2Cleared 510(K)
- K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set2Cleared 510(K)
- K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard2Cleared 510(K)
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests2Cleared 510(K)
- K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.2Cleared 510(K)
- K150606Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive2Cleared 510(K)
- K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls2Cleared 510(K)
- K151478Wondfo CR3 Keyless Split Sample Cup2Cleared 510(K)
- K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls2Cleared 510(K)
- K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 20002Cleared 510(K)
- K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls2Cleared 510(K)
- K150179CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids2Cleared 510(K)
- K141205LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 62Cleared 510(K)
- K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY2Cleared 510(K)
- K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)2Cleared 510(K)
- K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE2Cleared 510(K)
- K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)2Cleared 510(K)
- K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests2Cleared 510(K)
- K140748ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD2Cleared 510(K)
- K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS2Cleared 510(K)
- K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)2Cleared 510(K)
- K140089CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)2Cleared 510(K)
- K130650STATUS DS OXY2Cleared 510(K)
- K133642RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK2Cleared 510(K)
- K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY2Cleared 510(K)
- K130275QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST2Cleared 510(K)
- K122064FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE2Cleared 510(K)
- K130665WONDOFO MULTI-DRUG URINE TEST CUP / PANEL2Cleared 510(K)
- K130055ACON BUP ONE STEP BUPRENORPHINE TEST STRIP2Cleared 510(K)
- K123799PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR2Cleared 510(K)
- K113747RANDOX OPIATES ASSAY2Cleared 510(K)
- K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS2Cleared 510(K)
- K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS2Cleared 510(K)
- K111926PSYCHEMEDICS OPIATES EIA2Cleared 510(K)
- K113624WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST2Cleared 510(K)
- K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES2Cleared 510(K)
- K112310WONDFO METHADONE URINE TEST,OPIATE TEST2Cleared 510(K)
- K110298OPIATE ENZYME IMMUNOASSAY2Cleared 510(K)
- K101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY2Cleared 510(K)
- K102779EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C2Cleared 510(K)
- K093867ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A2Cleared 510(K)
- K100951MEDTOX BUPRENORPHINE TEST2Cleared 510(K)
- K093175WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES2Cleared 510(K)
- K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K100051INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)2Cleared 510(K)
- K100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM2Cleared 510(K)
- K091612UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;2Cleared 510(K)
- K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K091454PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM2Cleared 510(K)
- K081008BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS2Cleared 510(K)
- K082508FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD2Cleared 510(K)
- K063699IMDX SYSTEMS2Cleared 510(K)
- K063545MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE2Cleared 510(K)
- K063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC1502Cleared 510(K)
- K062460VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III2Cleared 510(K)
- K060760RAPIDONE-BUPRENORPHINE TEST2Cleared 510(K)
- K060527INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST2Cleared 510(K)
- K051958MP RAPIDOXY TEST STRIP, MODEL 07RD-70732Cleared 510(K)
- K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI001002Cleared 510(K)
- K060351MEDTOX OXYCODONE2Cleared 510(K)
- K052520RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC2Cleared 510(K)
- K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE2Cleared 510(K)
- K051626IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS2Cleared 510(K)
- K042725QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)2Cleared 510(K)
- K050733OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K042988RAPID ONE STEP BUPRENORPHINE TEST CARD2Cleared 510(K)
- K042990FOR SURE ONE STEP BUPRENORPHINE TEST STRIP2Cleared 510(K)
- K043507ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE2Cleared 510(K)
- K043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 91212Cleared 510(K)
- K041747IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)2Cleared 510(K)
- K041746IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)2Cleared 510(K)
- K041144RANDOX OPIATES ASSAY2Cleared 510(K)
- K040316CEDIA BUPRENORPHINE ASSAY2Cleared 510(K)
- K040274ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE2Cleared 510(K)
- K033047ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE2Cleared 510(K)
- K031032VERDICT II, PROFILE II2Cleared 510(K)
- K030113MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD232Cleared 510(K)
- K031002SYNCHRON SYSTEMS OPIATE REAGENT2Cleared 510(K)
- K023047AMEDICA DRUG SCREEN OPIATES TEST2Cleared 510(K)
- K020920COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE2Cleared 510(K)
- K020368OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)2Cleared 510(K)
- K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)2Cleared 510(K)
- K020371UPLINK TEST SYSTEM2Cleared 510(K)
- K014101RAPIDONE-OXY TEST2Cleared 510(K)
- K013314OPIATES2Cleared 510(K)
- K013482ABUSCREEN ONLINE OPIATES 300 / 20002Cleared 510(K)
- K013380ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE2Cleared 510(K)
- K013408AT HOME DRUG TEST, MODEL 90792Cleared 510(K)
- K013407AT HOME DRUG TEST, MODEL 90842Cleared 510(K)
- K012483AMEDITECH IMMUTEST DRUG SCREEN OPIATES2Cleared 510(K)
- K011353ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE2Cleared 510(K)
- K011150DRIDAU OPIATE ASSAY2Cleared 510(K)
- K011289EMIT II PLUS OPIATE ASSAY, MODEL OSR9B2292Cleared 510(K)
- K000851PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR2Cleared 510(K)
- K003209URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A2Cleared 510(K)
- K002268BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST2Cleared 510(K)
- K001178CEDIA DAU 6-ACETYLMORPHINE ASSAY2Cleared 510(K)
- K000464URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A2Cleared 510(K)
- K000273SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST2Cleared 510(K)
- K993151RADID DRUG SCREEN 5-PANEL TEST2Cleared 510(K)
- K994234AT HOME DRUG TEST, MODEL 90832Cleared 510(K)
- K992111VERDICT -II OPIATES 20002Cleared 510(K)
- K992890ROCHE COBAS INTEGRA OPIATES 300/20002Cleared 510(K)
- K993490QUICKSTRIP ONE STEP OPIATES TEST2Cleared 510(K)
- K993491QUICKPAC II ONE STEP OPIATES TEST2Cleared 510(K)
- K993165QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 91782Cleared 510(K)
- K991883REDI-TEST OPIATES2Cleared 510(K)
- K992422ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI20002Cleared 510(K)
- K990820RAPIDONE - OPIATES TEST2Cleared 510(K)
- K984152SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT2Cleared 510(K)
- K984232MODIFICATION OF EMIT D.A.U. OPIATES ASSAY2Cleared 510(K)
- K983190DBEST OPIATES TEST KIT2Cleared 510(K)
- K981771ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP2Cleared 510(K)
- K981341STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)2Cleared 510(K)
- K974840ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL2Cleared 510(K)
- K973761MICRO-STRIP FOR OPIATE METABOLITES2Cleared 510(K)
- K973153UBI MAGIWEL AMPHETAMINE METABOLITES2Cleared 510(K)
- K973156UBI MAGIWEL COCAINE METABOLITES2Cleared 510(K)
- K973155UBI MAGIWEL OPIATE METABOLITES2Cleared 510(K)
- K972619QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)2Cleared 510(K)
- K972571QUIKSTRIP ONE STEP OPIATES TEST2Cleared 510(K)
- K972405QUIKPAC II ONE STEP OPIATE TEST2Cleared 510(K)
- K971596EMIT II OPIATES 300/2000 ASSAY2Cleared 510(K)
- K971361AQ OPIATES (MORPHINE) TEST2Cleared 510(K)
- K962323IMMULITE OPIATES SCREEN/CONTROL MODULE2Cleared 510(K)
- K962795CEDIA DAU OPIATE 2K ASSAY2Cleared 510(K)
- K954498FRONTLINE OPIATES2Cleared 510(K)
- K952096ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)2Cleared 510(K)
- K935565OPIATES MICRO-PLATE ASSAY2Cleared 510(K)
- K951287AXSYM OPIATES2Cleared 510(K)
- K950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE2Cleared 510(K)
- K945608ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI2Cleared 510(K)
- K943248VISUALINE II MORPHINE/OPIATES/HEROIN2Cleared 510(K)
- K945343CEDIA DAU OPIATE ASSAY2Cleared 510(K)
- K944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS2Cleared 510(K)
- K943712VERDICT OPIATES2Cleared 510(K)
- K941041SOLOR CARE TECHNOLOGIES CORPORATION OPIATES2Cleared 510(K)
- K941195CEDIA DAU OPIATE ASSAY2Cleared 510(K)
- K935346CEDIA(R) DAU OPIATE ASSAY2Cleared 510(K)
- K935117EMIT(R) IIC OPIATE ASSAY2Cleared 510(K)
- K932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-2002Cleared 510(K)
- K924446MICRO-PLATE OPIATES ASSAY2Cleared 510(K)
- K923468MICRO EIA FOR OPIATE METABOLITES2Cleared 510(K)
- K921328STC DIAGNOSTICS AUTO-LYTE OPIATE EIA2Cleared 510(K)
- K915180OPIATE EIA ASSAY2Cleared 510(K)
- K913742IL TEST(TM) OPIATE2Cleared 510(K)
- K913863URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)2Cleared 510(K)
- K905491MICROLINE SCREEN FOR OPIATES2Cleared 510(K)
- K904997ABUSCREEN ONLINE TM FOR OPIATES2Cleared 510(K)
- K902924BIOSITE DIAGNOSTICS OPIATE SCREENING TEST2Cleared 510(K)
- K902577EMIT(R) II OPIATE ASSAY2Cleared 510(K)
- K902194MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K901577MILENIA(TM) OPIATES2Cleared 510(K)
- K900173HYCOR ACCUPINCH MORPHINE TEST2Cleared 510(K)
- K900203EZ-SCREEN:OPIATES2Cleared 510(K)
- K890978TARGET OPIATES-R2Cleared 510(K)
- K890979TARGET OPIATES-V2Cleared 510(K)
- K891605COAT-A-COUNT(TM) FENTANYL (TKFN1)2Cleared 510(K)
- K890888ABUSCREEN FP FOR MORPHINE2Cleared 510(K)
- K882496ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE2Cleared 510(K)
- K881941EMIT HVA OPIATE ASSAY2Cleared 510(K)
- K874808COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS52Cleared 510(K)
- K880010REVISED LABELING FOR ADX OPIATES2Cleared 510(K)
- K874485REVISED LABELING FOR OPIATES2Cleared 510(K)
- K874268REVISED LABELING FOR MORPHINE TEST KIT2Cleared 510(K)
- K873898REVISED LABELING FOR SYVA OPIATE ASSAYS2Cleared 510(K)
- K873757LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE2Cleared 510(K)
- K873758LABELING CHANGE COAT-A-COUNT SERUM MORPHINE2Cleared 510(K)
- K872391ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD2Cleared 510(K)
- K871698RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]2Cleared 510(K)
- K854421TDX R OPIATES2Cleared 510(K)
- K842677EMIT D.A.U. OPIATE ASSAY2Cleared 510(K)
- K843162EMIT 700 OPIATE ASSAY2Cleared 510(K)
- K833581MODIF. OF EMIT URINE OPIATE ASSAY2Cleared 510(K)
- 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
- QDRPlazomicin Test System, Immunoassay2Product 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
ARK Fentanyl II Assay
- Page Type
- Cleared 510(K)
- 510(k) Number
- K200197
- 510(k) Type
- Traditional
- Applicant
- ARK Diagnostics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/2020
- Days to Decision
- 30 days
- Submission Type
- Summary