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

    MICROPROTEIN REAGENT SET

    K Number: K070757 · Decision Dec 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    4
    Applicant Total
    74
    Review Days
    259

    Basic Information

    Device Name
    MICROPROTEIN REAGENT SET
    K Number
    K070757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    POINTE SCIENTIFIC, INC.
    Date Received
    March 20, 2007
    Decision Date
    December 4, 2007
    Product Code
    JGP
    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
    JGP Lowry (Colorimetric), Total Protein

    Similar 510(k) Clearances

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

    VITROS CHEMISTRY PRODUCTS UPRO SLIDES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROTEINMETER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEMATOLOGY DATA MANAGEMENT SYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICRO LOWRY PROTEINTEST

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

    Other Clearances by POINTE SCIENTIFIC, INC.

    K Number Device Name
    K062118 POINTE 360
    K070251 CARBON DIOXIDE LIQUID STABLE REAGENT
    K070207 MULTI-ANALYTE CHEMISTRY CALIBRATOR
    K070504 AMMONIA/ALCOHOL CONTROL SET
    K061377 APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    K051646 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
    K040391 TOTAL BILIRUBIN REAGENT SET
    K031539 HEMOGLOBIN A1C REAGENT SET
    K023860 MICROALBUMIN REAGENT SET AND CALIBRATORS
    K024006 G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
    Search all 74 clearances from POINTE SCIENTIFIC, INC. →