BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5

    K Number: K980833 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    321
    Review Days
    58

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    Basic Information

    Device Name
    IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
    K Number
    K980833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Products Corp.
    Date Received
    March 4, 1998
    Decision Date
    May 1, 1998
    Product Code
    JMM
    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
    JMM Column Chromatography & Color Development, Hydroxyproline

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    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
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    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
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