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

    HUMAN C-PEPTIDE REAGENTS

    K Number: K812288 · Decision Aug 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    18

    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 C-PEPTIDE REAGENTS
    K Number
    K812288
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1135
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immunex Radiochemical Diagnostics
    Date Received
    August 13, 1981
    Decision Date
    August 31, 1981
    Product Code
    JKD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKD Radioimmunoassay, C-Peptides Of Proinsulin

    Similar 510(k) Clearances

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

    AIA-PACK CPR ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMULITE C-PEPTIDE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DSL C-PEPTIDE RIA (DSL #7000)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DOUBLE ANTIBODY C-PEPTIDE RIA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    C-PEP-RIA-100

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    C-PEPTIDE RADIOIMMUNOASSAY TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all