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

    ANTITHROMBIN III SERUM, ANTI-HUMAN

    K Number: K781026 · Decision Aug 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    48
    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
    ANTITHROMBIN III SERUM, ANTI-HUMAN
    K Number
    K781026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Icl Scientific
    Date Received
    June 19, 1978
    Decision Date
    August 10, 1978
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

    Similar 510(k) Clearances

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

    INNOVANCE Antithrombin

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL ANTITHROMBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL LIQUID ANTITHROMBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL LIQUID ANTITHROMBIN XL

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

    Other Clearances by Icl Scientific

    K Number Device Name
    K883942 HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
    K843565 KOVA TROL I,II, III HUMAN URINE-DRIED
    K833761 THERAPEUTIC DRUG CONTROL
    K832823 ENZYMUNE-TEST TSH
    K831383 EVENT-TEST SLIDE
    K823199 ENZYME-TEST DIGOXIN
    K822346 HISTIMUNE ENZYME-ANA TEST
    K822777 THERAPEUTIC DRUG CONTROL
    K822465 ENZYMUNE SYSTEM I
    K821374 ENZYMUNE-TEST INSULIN
    Search all 48 clearances from Icl Scientific →