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

    BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT

    K Number: K861499 · Decision Jun 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
    K Number
    K861499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biostar Medical Products, Inc.
    Date Received
    April 23, 1986
    Decision Date
    June 20, 1986
    Product Code
    DAK
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DAK Complement C1q, Antigen, Antiserum, Control

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    Other Clearances by Biostar Medical Products, Inc.

    K Number Device Name
    K893896 QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
    K893897 SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
    K863238 READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
    K853697 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT