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

    ADRENOCORTICOTROPIC HORMONE TEST

    K Number: K833934 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    9
    Review Days
    142

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    Basic Information

    Device Name
    ADRENOCORTICOTROPIC HORMONE TEST
    K Number
    K833934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Clinetics Corp.
    Date Received
    November 14, 1983
    Decision Date
    April 4, 1984
    Product Code
    CKG
    Advisory Committee
    Clinical Chemistry
    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
    CKG Radioimmunoassay, Acth

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    Other Clearances by Clinetics Corp.

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    K841580 TSH RECEPTOR ANTIBODY KIT 125I TSH
    K830357 RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
    K823379 125-I FSH RADIOIMMUNOASSAY KIT
    K823380 125-I LH RADIOIMMUNOASSAY KIT
    K822152 HCG BETA RIA KIT
    K801306 CLINETICS PCA COLUMN