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

    ANGIOTENSIN I IMMUTOPE KIT

    K Number: K761267 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    ANGIOTENSIN I IMMUTOPE KIT
    K Number
    K761267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Squibb & Sons, Inc.
    Date Received
    December 16, 1976
    Decision Date
    December 30, 1976
    Product Code
    CIB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CIB Radioimmunoassay, Angiotensin I And Renin

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    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

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    Other Clearances by Squibb & Sons, Inc.

    K Number Device Name
    K821174 TSH-SQUIBB RADIOIMMUNOASSAY KIT
    K801424 ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
    K800750 STOMAHESIVE STERILE WAFER
    K770726 RIA KIT, T4 CLASP