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

    DOUBLE ANTIBODY CALCITONIN RIA KIT

    K Number: K861274 · Decision Jun 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    18
    Applicant Total
    321
    Review Days
    79

    Basic Information

    Device Name
    DOUBLE ANTIBODY CALCITONIN RIA KIT
    K Number
    K861274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    DIAGNOSTIC PRODUCTS CORP.
    Date Received
    April 7, 1986
    Decision Date
    June 25, 1986
    Product Code
    JKR
    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
    JKR Radioimmunoassay, Calcitonin

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    Other Clearances by DIAGNOSTIC PRODUCTS CORP.

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    K032881 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
    K023152 IMMULITE 2000 ALLERGEN-SPECIFIC IGE
    K023304 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
    K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
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