BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE

    K Number: K844171 · Decision Dec 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    632
    Review Days
    46

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
    K Number
    K844171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    October 25, 1984
    Decision Date
    December 10, 1984
    Product Code
    LGR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LGR), ordered by most recent decision date.

    ACS PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR PHENYTOIN ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXSYM PHENYTOIN II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TDX(R)/TDXFLX(R) PHENYTOIN II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXSYM PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →