BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ESTRIOL RIA KIT FOR USE WITH GAMMAFLO

    K Number: K801424 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
    K Number
    K801424
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1265
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Squibb & Sons, Inc.
    Date Received
    June 17, 1980
    Decision Date
    July 21, 1980
    Product Code
    CGI
    Advisory Committee
    Clinical Chemistry
    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
    CGI Radioimmunoassay, Estriol

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    Other Clearances by Squibb & Sons, Inc.

    K Number Device Name
    K821174 TSH-SQUIBB RADIOIMMUNOASSAY KIT
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    K770726 RIA KIT, T4 CLASP
    K761267 ANGIOTENSIN I IMMUTOPE KIT