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

    FREEZE DRIED PAPAIN

    K Number: K810803 · Decision Jul 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    119

    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
    FREEZE DRIED PAPAIN
    K Number
    K810803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Biological Corp. of America
    Date Received
    March 24, 1981
    Decision Date
    July 21, 1981
    Product Code
    KSK
    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
    KSK Solution, Stabilized Enzyme

    Similar 510(k) Clearances

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

    GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    FREEZE DRIED FICIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTOMATED ENZYME

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTOZYME

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

    Other Clearances by Biological Corp. of America

    K Number Device Name
    K813404 FREEZE DRIED FICIN
    K812565 ELUTION SOLUTION
    K812222 EM-X
    K781397 EM-V
    K760162 HEMATOLOGY CONTROL