LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K031367
    Device Name
    DUOPATH VEROTOXINS GLISA TEST
    Manufacturer
    EMD CHEMICALS INC.
    Date Cleared
    2004-01-23

    (268 days)

    Product Code
    GNA
    Regulation Number
    866.3255
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMD CHEMICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of verotoxins Fand if (Onlya like toking) produced by E. coli isolated in cultures derived promotion aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.
    Device Description
    Not Found
    Ask a Question
    K Number
    K990516
    Device Name
    ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    Manufacturer
    EMD CHEMICALS INC.
    Date Cleared
    1999-03-31

    (41 days)

    Product Code
    DNN
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMD CHEMICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the standardization of instruments and/or control materials.
    Device Description
    Not Found
    Ask a Question
    K Number
    K981926
    Device Name
    ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    Manufacturer
    EMD CHEMICALS INC.
    Date Cleared
    1998-07-22

    (50 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMD CHEMICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ammonia assay is used for the quantitation of ammonia in human plasma.
    Device Description
    Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NHzDPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NH2DP*. The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.
    Ask a Question
    K Number
    K973054
    Device Name
    ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    Manufacturer
    EMD CHEMICALS INC.
    Date Cleared
    1997-10-01

    (47 days)

    Product Code
    DNN
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMD CHEMICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1