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

    TECHLAB ASCA-CHEK

    K Number: K051927 · Decision Apr 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    36
    Review Days
    262

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    Basic Information

    Device Name
    TECHLAB ASCA-CHEK
    K Number
    K051927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5785
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techlab, Inc.
    Date Received
    July 18, 2005
    Decision Date
    April 6, 2006
    Product Code
    NBT
    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
    NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

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    K173217 CAMPYLOBACTER QUIK CHEK
    K173219 CAMPYLOBACTER CHEK
    K171078 TRI-COMBO PARASITE SCREEN
    K170728 E. HISTOLYTICA QUIK CHEK
    K082499 C. DIFF QUIK CHEK COMPLETE
    K053572 C. DIFF QUIK CHEK
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