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

    ESTRIOL-SQUIBB RIA KIT

    K Number: K802455 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    41
    Applicant Total
    32
    Review Days
    23

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    Basic Information

    Device Name
    ESTRIOL-SQUIBB RIA KIT
    K Number
    K802455
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1265
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E. R. Squibb & Sons, Inc.
    Date Received
    October 8, 1980
    Decision Date
    October 31, 1980
    Product Code
    CGI
    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
    CGI Radioimmunoassay, Estriol

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    Other Clearances by E. R. Squibb & Sons, Inc.

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    K820341 CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
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    K811239 SUR-FIT DISPOSABLE CONVEX INSERT
    K811160 SUR-FIT IRRIGATION SLEEVE
    K811163 SUR-FIT DISPOSABLE FANGE CAP
    K810966 DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
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