BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HUMAN SERUM - STERILE FILTERED

    K Number: K861812 · Decision May 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    47
    Review Days
    11

    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
    HUMAN SERUM - STERILE FILTERED
    K Number
    K861812
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hazleton Research Products, Inc.
    Date Received
    May 9, 1986
    Decision Date
    May 20, 1986
    Product Code
    KIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIS Sera, Animal And Human

    Similar 510(k) Clearances

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

    ANIMAL AND HUMAN SERA

    FDA 510(k)
    FDA Class 1 ·Hematology

    BOVINE CALF SERUM SUPPLEMENTED #A-2159

    FDA 510(k)
    FDA Class 1 ·Hematology

    BOVINE CALF SERUM CATALOG #A-2119

    FDA 510(k)
    FDA Class 1 ·Hematology

    SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    MLC NORMAL SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology

    FETAL BOVINE SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by Hazleton Research Products, Inc.

    K Number Device Name
    K861997 PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
    K861996 DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM
    K861875 RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER
    K861872 ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM
    K861870 DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER
    K861873 MEM GLASGOW MEDIUM
    K861886 DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM
    K861869 GENTAMICIN-50MG/ML
    K861885 WILLIAMS MEDIUM E POWDER
    K861871 NCTC 109 MEDIUM
    Search all 47 clearances from Hazleton Research Products, Inc. →