BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR

    K Number: K041627 · Decision Sep 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    79

    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
    CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
    K Number
    K041627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dako A/S
    Date Received
    June 16, 2004
    Decision Date
    September 3, 2004
    Product Code
    NDY
    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
    NDY Test, Cystatin C

    Similar 510(k) Clearances

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

    Cystatin C

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N Latex Cystatin C; N Protein Standard UY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tina-quant Cystatin C Gen.2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIAZYME CYSTATIN C POC TEST KIT

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

    Other Clearances by Dako A/S

    K Number Device Name
    K032692 DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368