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

    VOLU-SOL ORANGE G-6 STAIN

    K Number: K800323 · Decision Feb 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    66
    Review Days
    10

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    Basic Information

    Device Name
    VOLU-SOL ORANGE G-6 STAIN
    K Number
    K800323
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Volu Sol Medical Industries
    Date Received
    February 12, 1980
    Decision Date
    February 22, 1980
    Product Code
    HZH
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HZH Orange G

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    K822129 VOLU-SOL BOVINS FIXATIVE
    K822036 VOLU-SOL DECALCIFER
    K822035 VOLU-SOL GILLS EA
    K822038 VOLU-SOL ORANGE G-6(GILLS-MOD
    K822037 VOLU-SOL TAP WATER SUBSTITUTE
    K812906 ELVI BICLOT 816
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