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

    AURAMINE O MYCROBACTERIAL STAIN SET

    K Number: K812274 · Decision Sep 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    24
    Review Days
    19

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    Basic Information

    Device Name
    AURAMINE O MYCROBACTERIAL STAIN SET
    K Number
    K812274
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Carr-Scarborough Microbiologicals, Inc.
    Date Received
    August 13, 1981
    Decision Date
    September 1, 1981
    Product Code
    KJK
    Advisory Committee
    Hematology
    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
    KJK Auramine O

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    K891476 C. ALBICANS SCREEN
    K882630 PRO DISCS
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    K863216 NEIS NZY
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