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

    ALUMINA SILICA-ACTIVATED PARTIAL THROM

    K Number: K820835 · Decision Apr 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    44
    Review Days
    31

    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
    ALUMINA SILICA-ACTIVATED PARTIAL THROM
    K Number
    K820835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    March 26, 1982
    Decision Date
    April 26, 1982
    Product Code
    GFO
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    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 Hyland Therapeutic Div., Travenol Laboratories

    K Number Device Name
    K820192 HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
    K812220 NEPHELOMETRIC SOLID TURBIDITY STANDARD
    K810078 Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
    K810077 OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
    K790249 TEST CELLS
    K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING
    K780962 AUTOMATED ENZYME
    K780785 DILUTOR TRANSPORTER
    Search all 44 clearances from Hyland Therapeutic Div., Travenol Laboratories →