BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    HCG CONTROLS

    K Number: K970176 · Decision Feb 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    8
    Review Days
    20

    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
    HCG CONTROLS
    K Number
    K970176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Newtech Development, Inc.
    Date Received
    January 17, 1997
    Decision Date
    February 6, 1997
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON EBV IgM Serum Control Set

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

    Other Clearances by International Newtech Development, Inc.

    K Number Device Name
    K993850 URINALYSIS REAGENT STRIPS (10 PARAMETERS)
    K974060 MINISTRIP/ SERUM AND URINE COMBO HCG TEST
    K974059 ONE STEP MIDSTREAM HCG PREGNANCY TEST
    K974009 PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
    K963132 MINI STRIP/SERUM HCG
    K963133 PS-UNIT CASSETTE/SERUM HCG
    K951705 MINISTRIP HCG