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- 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
- K011275PSYCHEMEDICS RIA PHENCYCLIDINE ASSAYUCleared 510(K)
- K994093AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CUCleared 510(K)
- K913864PCP DIRECT RIA KIT (I-125)UCleared 510(K)
- K890882ABUSCREEN FP FOR PHENCYCLIDINEUCleared 510(K)
- K882179EMIT HVA PHENCYCLIDINE ASSAYUCleared 510(K)
- K880011REVISED LABELING FOR ADX PHENCYCLIDINEUCleared 510(K)
- K874626REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYSUCleared 510(K)
- K874484REVISED LABELING FOR TDX PHENCYCLIDINEUCleared 510(K)
- K830481ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINEUCleared 510(K)
- K800514PHENCYCLIDINE DIRECT BLOOD RIA KITUCleared 510(K)
Show All 11 Submissions
- LCMEnzyme Immunoassay, PhencyclidineUProduct Code
- 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
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K830481
- 510(k) Type
- Traditional
- Applicant
- HOFFMANN-LA ROCHE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/24/1983
- Days to Decision
- 37 days