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

    DELFIA(TM) CORTISOL KIT

    K Number: K863422 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    52
    Review Days
    22

    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
    DELFIA(TM) CORTISOL KIT
    K Number
    K863422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lkb Instruments, Inc.
    Date Received
    September 4, 1986
    Decision Date
    September 26, 1986
    Product Code
    JFT
    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
    JFT Fluorometric, Cortisol

    Similar 510(k) Clearances

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

    Elecsys Cortisol III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Cortisol (COR)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys Cortisol II, Cortisol II CalSet

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Cortisol (COR) Assy

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARCHITECT CORTISOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM CORTISOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Lkb Instruments, Inc.

    K Number Device Name
    K874094 1205 BETAPLATE LIQUID SCINTILLATION COUNTER
    K872955 DELFIA(TM) FERRITIN KIT
    K871303 DELFIA(TM) THYROXINE (T4) KIT
    K871599 DELFIA(TM) HIGE KIT
    K871644 DELFIA (TM) HTSH KIT
    K864452 DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
    K864733 LKB 2260 MACROTOME
    K862848 LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110
    K861195 DELFIA DIGOXIN
    K862044 DELFIA (TM) HCG KIT
    Search all 52 clearances from Lkb Instruments, Inc. →