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

    OSOM ULTRA STREP A TEST, MODEL 147

    K Number: K992658 · Decision Jan 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    12
    Review Days
    162

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    Basic Information

    Device Name
    OSOM ULTRA STREP A TEST, MODEL 147
    K Number
    K992658
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wyntek Diagnostics, Inc.
    Date Received
    August 9, 1999
    Decision Date
    January 18, 2000
    Product Code
    GTY
    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
    GTY Antigens, All Groups, Streptococcus Spp.

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    Other Clearances by Wyntek Diagnostics, Inc.

    K Number Device Name
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    K973879 OSOM CARD HCG-URINE TEST
    K972231 OSOM MONO TEST 143
    K965227 OSOM CLASSIC HCG-URINE TEST (115)
    K965184 PERFECTA PREGNANCY TEST
    K961423 OSOM STREP A TEST
    K955141 OSOM HCG COMBO TEST
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