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

    SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV

    K Number: K854245 · Decision Jan 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    164
    Review Days
    93

    Basic Information

    Device Name
    SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
    K Number
    K854245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1090
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    SIGMA DIAGNOSTICS, INC.
    Date Received
    October 21, 1985
    Decision Date
    January 22, 1986
    Product Code
    KQN
    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
    KQN Radioassay, Angiotensin Converting Enzyme

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    Other Clearances by SIGMA DIAGNOSTICS, INC.

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    K013549 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
    K013544 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    K013545 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
    K012410 INFINITY HBA KIT, MODELS 537-A, 537-B
    K010652 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
    K010158 THROMBOMAX-HS WITH CALCIUM, MODEL T6540
    K003267 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
    K003329 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
    Search all 164 clearances from SIGMA DIAGNOSTICS, INC. →