Anesthesiology
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- HematologyReview Panel
- ImmunologyReview Panel
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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
- 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)
Show All 88 Submissions
- 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
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K101746
- 510(k) Type
- Traditional
- Applicant
- Microgenics Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/8/2011
- Days to Decision
- 290 days
- Submission Type
- Summary