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

    RADIOIMMUNOASSAY, HUMAN CHORRIONIC

    K Number: K822840 · Decision Oct 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    9
    Review Days
    34

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY, HUMAN CHORRIONIC
    K Number
    K822840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bioclinical Group
    Date Received
    September 23, 1982
    Decision Date
    October 27, 1982
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Bioclinical Group

    K Number Device Name
    K862968 FREE T3 RADIOIMMUNOASSAY KIT
    K853837 LH/FSH RADIOIMMUNOASSAY KIT
    K832638 CORTISOL RADIOIMMUNOASSAY KIT
    K823005 BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
    K823004 BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
    K822515 B-HCG RADIOIMMUNOASSAY KIT
    K821241 FREE T4 RADIOIMMUNOASSAY KIT
    K821101 TOTAL RADIOIMMUNOASSAY KIT