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

    MODIFICATION OF SAS SERUM/URINE HCG

    K Number: K990684 · Decision May 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    199
    Review Days
    68

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    Basic Information

    Device Name
    MODIFICATION OF SAS SERUM/URINE HCG
    K Number
    K990684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sa Scientific, Inc.
    Date Received
    March 3, 1999
    Decision Date
    May 10, 1999
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Sa Scientific, Inc.

    K Number Device Name
    K100227 SAS FLUALERT A&B, SAS INFLUENZA A TEST
    K080380 SAS INFLUENZA A & B TEST
    K041439 SAS INFLUENZA B TEST
    K041441 SAS INFLUENZA A TEST
    K030628 SAS RSV CONTROL KIT
    K022845 SAS RSV TEST
    K022683 SAS BLOOD/SERUM/URINE/URINE HCG
    K023270 SAS STREPALERT
    K020438 SAS VALUE HCG
    K013379 SAS STREPALERT
    Search all 199 clearances from Sa Scientific, Inc. →