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

    IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN

    K Number: K831961 · Decision Aug 11, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    40
    Review Days
    55

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    Basic Information

    Device Name
    IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
    K Number
    K831961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    June 17, 1983
    Decision Date
    August 11, 1983
    Product Code
    JBQ
    Advisory Committee
    Hematology
    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
    JBQ Antithrombin Iii Quantitation

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    Other Clearances by Kent Laboratories, Inc.

    K Number Device Name
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    K951968 HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
    K950102 HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
    K850683 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
    K850682 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
    K850691 ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
    K850690 ANTISERUM TO HUMAN APOLIPOPROTEIN B
    K850686 ANTISERUM TO HUMAN PREALBUMIN
    K831958 RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
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