BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

    K Number: K103487 · Decision Oct 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    123
    Review Days
    312

    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
    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
    K Number
    K103487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taidoc Technology Corporation
    Date Received
    November 26, 2010
    Decision Date
    October 4, 2011
    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 Taidoc Technology Corporation

    K Number Device Name
    K221349 XPER Technology PREMIUM Pro Blood Glucose Monitoring System
    K201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
    K200946 Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
    K190579 TD-4183 Blood Glucose Monitoring System
    K182934 FORA P100 Blood Pressure Monitoring System
    K180863 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
    K181675 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
    K181588 POPS! one Blood Glucose Monitoring System
    K172733 TD-1035 Thermometer
    K173511 ActiveCare TD-4121 Blood Glucose Monitoring System
    Search all 123 clearances from Taidoc Technology Corporation →