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

    PERFECTA PREGNANCY TEST

    K Number: K965184 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    12
    Review Days
    42

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    Basic Information

    Device Name
    PERFECTA PREGNANCY TEST
    K Number
    K965184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wyntek Diagnostics, Inc.
    Date Received
    December 24, 1996
    Decision Date
    February 4, 1997
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Wyntek Diagnostics, Inc.

    K Number Device Name
    K992658 OSOM ULTRA STREP A TEST, MODEL 147
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    K990576 OSOM CARD PREGNANCY TEST, MODEL 103
    K974159 OSOM HCG-URINE TEST MODEL 101
    K973879 OSOM CARD HCG-URINE TEST
    K972231 OSOM MONO TEST 143
    K965227 OSOM CLASSIC HCG-URINE TEST (115)
    K961423 OSOM STREP A TEST
    K955141 OSOM HCG COMBO TEST
    K954178 OSOM PREGNANCY TEST
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