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

    SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT

    K Number: K982608 · Decision Aug 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    5
    Review Days
    23

    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
    SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
    K Number
    K982608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangui Biotech, Inc.
    Date Received
    July 27, 1998
    Decision Date
    August 19, 1998
    Product Code
    CKG
    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
    CKG Radioimmunoassay, Acth

    Similar 510(k) Clearances

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

    IDS ACTH II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

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

    Other Clearances by Sangui Biotech, Inc.

    K Number Device Name
    K001943 CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
    K992799 SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
    K982491 SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
    K974306 SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA