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

    WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S

    K Number: K852138 · Decision Jun 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    32
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
    K Number
    K852138
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Canyon Diagnostics, Inc.
    Date Received
    May 16, 1985
    Decision Date
    June 13, 1985
    Product Code
    IAF
    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
    IAF Wright'S Stain

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