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

    RENCTK

    K Number: K800774 · Decision Apr 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    20
    Review Days
    14

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    Basic Information

    Device Name
    RENCTK
    K Number
    K800774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    April 7, 1980
    Decision Date
    April 21, 1980
    Product Code
    CIB
    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
    CIB Radioimmunoassay, Angiotensin I And Renin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CIB), ordered by most recent decision date.

    IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS

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    LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT

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    CISBIO RENIN RIA TEST

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    ACTIVE RENIN IRMA

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    NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)

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    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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