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

    GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY

    K Number: K842079 · Decision Jun 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    30
    Review Days
    34

    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
    GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
    K Number
    K842079
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1325
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immuno Nuclear Corp.
    Date Received
    May 23, 1984
    Decision Date
    June 26, 1984
    Product Code
    CGC
    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
    CGC Radioimmunoassay, Gastrin

    Similar 510(k) Clearances

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

    GASTRIN EIA MODEL 06B-555017

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GASTRIN RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DPC GASTRIN KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BLOOD GAS & FLAME PHOTOMETER INSTRU-

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GASTRIN RADIOIMMUNOASSAY KIT (125-I)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT

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

    Other Clearances by Immuno Nuclear Corp.

    K Number Device Name
    K863743 BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
    K863973 ELM ALLERGEN DISC
    K863844 IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
    K863123 IMMUNO BIOTECH MUGWART ALLERGEN DISC
    K863098 MEADOW FESCUE ALLERGEN DISC
    K862266 MAPLE ALLERGEN DISC
    K862938 JUNE GRASS ALLERGEN DISC
    K862176 RUSSIAN THISTLE ALLERGEN DISC
    K862265 COTTONWOOD ALLERGEN DISC
    K862939 ORCHARD GRASS ALLERGEN DISC
    Search all 30 clearances from Immuno Nuclear Corp. →