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

    VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS

    K Number: K943866 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    164
    Review Days
    94

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    Basic Information

    Device Name
    VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
    K Number
    K943866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    August 8, 1994
    Decision Date
    November 10, 1994
    Product Code
    LEG
    Advisory Committee
    Clinical Toxicology
    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
    LEG Enzyme Immunoassay, Valproic Acid

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    Other Clearances by Sigma Diagnostics, Inc.

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    K020109 SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
    K013549 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
    K013544 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    K013545 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
    K012410 INFINITY HBA KIT, MODELS 537-A, 537-B
    K010652 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
    K010158 THROMBOMAX-HS WITH CALCIUM, MODEL T6540
    K003267 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
    K003329 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
    Search all 164 clearances from Sigma Diagnostics, Inc. →