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

    CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

    K Number: K032159 · Decision Sep 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    4
    Review Days
    52

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
    K Number
    K032159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Access Bio Incorporate
    Date Received
    July 15, 2003
    Decision Date
    September 5, 2003
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.

    MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Shinetell PlusTM Digital Early Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Access Bio Incorporate

    K Number Device Name
    K051925 CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
    K031048 CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
    K031052 CARESTART HCG ONE-STEP PREGNANCY TEST