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

    PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

    K Number: K102841 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    16
    Review Days
    587

    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
    PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
    K Number
    K102841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pantex, Div. Bio-Analysis, Inc.
    Date Received
    September 29, 2010
    Decision Date
    May 8, 2012
    Product Code
    NHG
    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
    NHG Enzyme Immunoassay, Cortisol, Salivary

    Similar 510(k) Clearances

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

    Cortisol Saliva Luminescence Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS CORTISOL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102

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

    Other Clearances by Pantex, Div. Bio-Analysis, Inc.

    K Number Device Name
    K942658 NEOSCREEN ELISA TSH
    K914107 PROLACTIN IRMA IMMUNOMAG
    K912804 FSH IRMA IMMUNOMAG
    K911839 NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
    K911050 LH IRMA IMMUNOMAG
    K910717 PANTEX IRMA LH 1251 KIT
    K894049 IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
    K862483 PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
    K862447 PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
    K862336 PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
    Search all 16 clearances from Pantex, Div. Bio-Analysis, Inc. →