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

    THE THERATEST ACA TEST

    K Number: K905301 · Decision Jan 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    22
    Review Days
    48

    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
    THE THERATEST ACA TEST
    K Number
    K905301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Theratest Laboratories, Inc.
    Date Received
    November 27, 1990
    Decision Date
    January 14, 1991
    Product Code
    GFO
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GFO Activated Partial Thromboplastin

    Similar 510(k) Clearances

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

    HemosIL Silica Clotting Time

    FDA 510(k)
    FDA Class 2 ·Hematology

    Cryocheck Hex LA

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL Silica Clotting Time

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA-CEPHASCREEN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL SYNTHASIL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL SILICA CLOTTING TIME

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Theratest Laboratories, Inc.

    K Number Device Name
    K090753 THERATEST EL-ANTI-CCP/2
    K090760 THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
    K071692 THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
    K061376 EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
    K060176 EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    K051066 THERATEST EL-ANA PROFILES
    K040291 EL-ANA PROFILES: ANTI-CHROMATIN
    K024031 THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
    K024151 EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
    K002559 EL-ANA PROFILES-2K1
    Search all 22 clearances from Theratest Laboratories, Inc. →