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

    RENAK

    K Number: K831694 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    49
    Review Days
    56

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    Basic Information

    Device Name
    RENAK
    K Number
    K831694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    May 24, 1983
    Decision Date
    July 19, 1983
    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

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    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

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    Other Clearances by Hoffmann-La Roche, Inc.

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    K830480 ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
    K830461 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
    K830460 ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
    K830482 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
    K830462 ABUSCREEN RADIOUMMUNOASSAY--URINE
    K830479 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
    K823579 COBAS REAGENT FOR TOTAL PROTEIN
    K823578 COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
    Search all 49 clearances from Hoffmann-La Roche, Inc. →