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

    RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E

    K Number: K830357 · Decision Mar 17, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
    K Number
    K830357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Clinetics Corp.
    Date Received
    February 3, 1983
    Decision Date
    March 17, 1983
    Product Code
    DGC
    Advisory Committee
    Immunology
    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
    DGC Ige, Antigen, Antiserum, Control

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    Other Clearances by Clinetics Corp.

    K Number Device Name
    K862180 MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
    K844066 COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
    K841580 TSH RECEPTOR ANTIBODY KIT 125I TSH
    K833934 ADRENOCORTICOTROPIC HORMONE TEST
    K823379 125-I FSH RADIOIMMUNOASSAY KIT
    K823380 125-I LH RADIOIMMUNOASSAY KIT
    K822152 HCG BETA RIA KIT
    K801306 CLINETICS PCA COLUMN