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

    BECKMAN B-4 TEB BUFFER KIT

    K Number: K791290 · Decision Aug 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    281
    Review Days
    24

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    Basic Information

    Device Name
    BECKMAN B-4 TEB BUFFER KIT
    K Number
    K791290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7440
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    July 10, 1979
    Decision Date
    August 3, 1979
    Product Code
    JBD
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JBD System, Analysis, Electrophoretic Hemoglobin

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    Other Clearances by Beckman Instruments, Inc.

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    K981403 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
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    K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
    K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
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