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

    IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6

    K Number: K993251 · Decision Nov 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    7
    Applicant Total
    321
    Review Days
    50

    Basic Information

    Device Name
    IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
    K Number
    K993251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DIAGNOSTIC PRODUCTS CORP.
    Date Received
    September 28, 1999
    Decision Date
    November 17, 1999
    Product Code
    LIG
    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
    LIG Radioassay, Intrinsic Factor Blocking Antibody

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    Other Clearances by DIAGNOSTIC PRODUCTS CORP.

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    K033234 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
    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)
    K021206 IMMULITE 2000 SPECIFIC ALLERGENS
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