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

    COLOR VUE TM- MYCOPLASMA PNEUMONIAE

    K Number: K910833 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    28
    Review Days
    117

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    Basic Information

    Device Name
    COLOR VUE TM- MYCOPLASMA PNEUMONIAE
    K Number
    K910833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Seradyn, Inc.
    Date Received
    February 27, 1991
    Decision Date
    June 24, 1991
    Product Code
    GSA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GSA Antisera, All Mycoplasma Spp.

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