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

    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

    K Number: K981607 · Decision May 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    94
    Review Days
    22

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    Basic Information

    Device Name
    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
    K Number
    K981607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    May 5, 1998
    Decision Date
    May 27, 1998
    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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    Other Clearances by Diagnostic Systems Laboratories, Inc.

    K Number Device Name
    K061758 ACTIVE RENIN IRMA
    K020945 AXSYM INTACT PTH, MODEL 2G06
    K020128 ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
    K002128 ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
    K001086 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
    K990138 DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
    K981871 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    K973243 ACTIVE PSA ELISA (DSL-10-9700)
    K973244 ACTIVE PSA IRMA (DSL-9700)
    K973514 ACTIVE INTACT PTH
    Search all 94 clearances from Diagnostic Systems Laboratories, Inc. →