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

    CBR-DIGOXIN ANTISERUM

    K Number: K780498 · Decision Apr 5, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    8

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    Basic Information

    Device Name
    CBR-DIGOXIN ANTISERUM
    K Number
    K780498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Bioresearch
    Date Received
    March 28, 1978
    Decision Date
    April 5, 1978
    Product Code
    DKA
    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
    DKA Antiserum, Digoxin

    Similar 510(k) Clearances

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

    STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY

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    RABBIT ANTIBODY TO DIGOXIN

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    FDA Class 2 ·Clinical Toxicology
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    Other Clearances by Clinical Bioresearch

    K Number Device Name
    K780707 T4-RIA KIT
    K780499 CBR-T3RIA KIT
    K780500 CBR-T3 UPTAKE KIT