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
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUProduct Code
- NGMTest, Phencyclidine (Pcp), Over The CounterUProduct Code
- OTWResearch Use Only/Clinical ToxicologyNProduct Code
- OXR5-Fluorouracil AssayNProduct Code
- PDBInvestigational Use Only - Clinical ToxicologyNProduct Code
- PGEGastric Emptying Breath Test3Product Code
- PKMChemiluminescent Immunoassay SystemNProduct Code
- PRFDocetaxel / Paclitaxel AssayNProduct Code
- PSSMinoxidil Sulfotransferase Or Isoenzymes Test SystemNProduct Code
- LAOEnzyme Immunoassay, MethotrexateUProduct Code
- LCLRadioimmunoassay, PhencyclidineUProduct Code
- LCMEnzyme Immunoassay, PhencyclidineUProduct Code
- K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairUCleared 510(K)
- K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayUCleared 510(K)
- K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayUCleared 510(K)
- K163220Atellica CH Phencyclidine (Pcp)UCleared 510(K)
- K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsUCleared 510(K)
- K142044CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINEUCleared 510(K)
- K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEUCleared 510(K)
- K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORUCleared 510(K)
- K111928PSYCHEMEDICS PHENCYCLIDINE EIAUCleared 510(K)
- K101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYUCleared 510(K)
- K093989ORAL FLUID PHENCYCLIDINEUCleared 510(K)
- K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINEUCleared 510(K)
- K080431RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054UCleared 510(K)
- K062094VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & VUCleared 510(K)
- K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000UCleared 510(K)
- K042726QUEST DIAGNOSTICS HAIRCHECK-DT (PCPUCleared 510(K)
- K043071RANDOX PHENCYCLIDINE ASSAYUCleared 510(K)
- K043305ONLINE DAT PHENCYCLIDINE PLUSUCleared 510(K)
- K041578QUICKSCREEN, MODELS 9177X AND 9178XUCleared 510(K)
- K023109AMEDICA DRUG SCREEN PHENCYCLIDINE TESTUCleared 510(K)
- K020254PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011UCleared 510(K)
- K013096PHENCYCLIDINEUCleared 510(K)
- K012582AMEDITECH IMMUTEST DRUG SCREEN PCPUCleared 510(K)
- K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICEUCleared 510(K)
- K012107LIVESURE PHENECYCLINE (PCP) SCREEN TESTSUCleared 510(K)
- K010047INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TESTUCleared 510(K)
- K010045INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TESTUCleared 510(K)
- K011161MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229UCleared 510(K)
- K010651AT HOME DRUG TEST, MODEL 9133 TUCleared 510(K)
- K002272BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160DUCleared 510(K)
- K002776MODIFICATION TO PROFILE -IIUCleared 510(K)
- K000399STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541UCleared 510(K)
- K000402SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TESTUCleared 510(K)
- K000462URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94AUCleared 510(K)
- K994020ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2UCleared 510(K)
- K994017ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1UCleared 510(K)
- K994030ONTRAK TESTCUP 5, CAT. 07 6481 7UCleared 510(K)
- K993983SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029ULUCleared 510(K)
- K994236AT HOME DRUG TEST, MODEL 9133UCleared 510(K)
- K993945BIONIKE AQ PHENCYCLIDINE (PCP) TESTUCleared 510(K)
- K991698REDI-TEST PCPUCleared 510(K)
- K991505MICRO-STRIP FOR PHENCYCLIDINE METABOLITESUCleared 510(K)
- K983790VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINEUCleared 510(K)
- K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTUCleared 510(K)
- K982801AUTO-LYTE PCP EIA, MODEL #1254UUCleared 510(K)
- K981292QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TESTUCleared 510(K)
- K981019QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TESTUCleared 510(K)
- K974582QUICKSCREEN ONE STEP PCP SCREENING TESTUCleared 510(K)
- K972963MODIFIED CEDIA DAU PCP ASSAYUCleared 510(K)
- K964355ONTRAK TESTCUP 5 (MODIFICATION)UCleared 510(K)
- K963692VERDICT PCPUCleared 510(K)
- K963233EZ-SCREEN PROFILEUCleared 510(K)
- K961266ACCUSIGN, BIOSIGN PCPUCleared 510(K)
- K953534AXSYM PHENCYCLIDINE IIUCleared 510(K)
- K950183URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGEUCleared 510(K)
- K935191EMIT IIC PHENCYCLIDINE ASSAYUCleared 510(K)
- K946059CEDIA(R) DAU PCP ASSAYUCleared 510(K)
- K944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMUCleared 510(K)
- K943711EZ-SCREEN:PCPUCleared 510(K)
- K935629USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400UCleared 510(K)
- K935650CEDIA(R) DAU PCP ASSAYUCleared 510(K)
- K935320PHENCYCLIDINE EIA ASSAYUCleared 510(K)
- K924751SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAYUCleared 510(K)
- K924462STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIAUCleared 510(K)
- K921651MICROLINE SCREEN FOR PHENCYCLIDINEUCleared 510(K)
- K920935ABUSCREEN ONLINE FOR PHENCYCLIDINEUCleared 510(K)
- K920957PHENCYCLIDINE EIA ASSAY, MODIFICATIONUCleared 510(K)
- K915728EMIT D.A.U. PHENCYCLIDINE ASSAYUCleared 510(K)
- K915179PHENCYCLIDINE EIA ASSAYUCleared 510(K)
- K913743IL TEST(TM) PHENCYCLIDINEUCleared 510(K)
- K911153MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KTUCleared 510(K)
- K911725ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHODUCleared 510(K)
- K904765EMIT (R) II PHENCYCLIDINE ASSAYUCleared 510(K)
- K902960MILENIA(TM) PCPUCleared 510(K)
- K900921HYCOR ACCUPINCH PHENCYCLIDINE TESTUCleared 510(K)
- K900940TDX PHENCYCLIDINE II ASSAYUCleared 510(K)
- K895906ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)UCleared 510(K)
- K890688ADX TM PHENCYCLIDINEUCleared 510(K)
- K874267REVISED LABELING FOR PCP TEST KITUCleared 510(K)
- K873756LABELING CHANGE PCP (PHENCYCLIDINE) IN URINEUCleared 510(K)
- K854167TDX PHENCYCLIDINEUCleared 510(K)
- K853548STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASSUCleared 510(K)
- K843509EMIT 700 PHENCYCLIDINE ASSAYUCleared 510(K)
- K840199EMIT ST SERUM PHENCYCLIDINE ASSAYUCleared 510(K)
- K840061EMIT ST URINE PHENCYCLIDINE ASSAYUCleared 510(K)
- K810601EMIT-ST SERUM PHENCYCLIDINE ASSAYUCleared 510(K)
- K810093EMIT-ST PHENCYCLIDINE ASSAYUCleared 510(K)
- K790401PHENCYCLIDINE URINE ASSAYUCleared 510(K)
- LTDParaquat Assay3Product Code
- MGXTest System, For Drugs Of Abuse3Product Code
- MIGStrip, Test IsoniazidUProduct Code
- MSKImmunoassay For Blood TacrolimusNProduct Code
- PZNPlacental Growth Factor TestNProduct Code
- QBBPlacental Alpha Microglobulin-1 Immunoassay3Product Code
- QWHPrognostic Test For Development Or Progression Of Preeclampsia2Product Code
- QXTInfliximab Test System2Product Code
- QYDAdalimumab Assay2Product Code
- QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- 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 TESTSTIK FOR PCP, CAT. 07 6654 2
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K994020
- 510(k) Type
- Traditional
- Applicant
- Roche Diagnostics Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/27/2000
- Days to Decision
- 62 days
- Submission Type
- Summary