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

    LIQUI-SERA TDM CALIBRATORS

    K Number: K834398 · Decision Feb 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    11
    Review Days
    51

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    Basic Information

    Device Name
    LIQUI-SERA TDM CALIBRATORS
    K Number
    K834398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Biodiagnostic Intl
    Date Received
    December 14, 1983
    Decision Date
    February 3, 1984
    Product Code
    DKB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DKB Calibrators, Drug Mixture

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    Other Clearances by Biodiagnostic Intl

    K Number Device Name
    K031296 LIQUI-HEME GLYCO A1C ASSAY
    K881430 LIQUI-SERA SERUM ALCOHOL CONTROLS
    K874459 LIQUI-SERA SPINAL FLUID CONTROL
    K863849 LIQUI-SERA COMBO LIGAND/TDM CONTROLS
    K853906 LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)
    K853887 LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
    K842668 LIQUI-HEME HEMOGLOBIN CALIBRATORS
    K840618 LIQUI-URA CHEMISTRY URINE CONTROLS
    K834259 LIQUI-URA TOXIC URINE CONTROL
    K831278 LIQUI-SERA ANTICONVULSANTS CONTROLS
    Search all 11 clearances from Biodiagnostic Intl →