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

    CISBIO RENIN RIA TEST

    K Number: K062120 · Decision Mar 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    248

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CISBIO RENIN RIA TEST
    K Number
    K062120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cis Bio International
    Date Received
    July 25, 2006
    Decision Date
    March 30, 2007
    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

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE RENIN IRMA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

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

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BUHLMANN ANGIOSTENSIN II RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all