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

    ADVANCE PREGNANCY TEST MODIFICATION

    K Number: K934516 · Decision Feb 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    9
    Review Days
    160

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    Basic Information

    Device Name
    ADVANCE PREGNANCY TEST MODIFICATION
    K Number
    K934516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Pharmaceutical Corp.
    Date Received
    September 17, 1993
    Decision Date
    February 24, 1994
    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 Ortho Pharmaceutical Corp.

    K Number Device Name
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    K881151 MICROSCRAPE
    K810581 FACT* HOME PREGNANCY TEST
    K800754 NICKERSON'S MED. SELECTIVE CULTURE MEDIU
    K792634 CONCEPTROL/THIN PROPHYLACTICS
    K790087 LUBRICANT, OTRHO PERSONAL