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

    TOTAL GALACTOSE

    K Number: K894011 · Decision Jan 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    33
    Review Days
    219

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    Basic Information

    Device Name
    TOTAL GALACTOSE
    K Number
    K894011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1315
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alpkem Corp.
    Date Received
    June 6, 1989
    Decision Date
    January 11, 1990
    Product Code
    KQP
    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
    KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

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    Other Clearances by Alpkem Corp.

    K Number Device Name
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    K890336 GLUCOSE (GOD) REAGENT
    K890332 RFA/2 RAPID FLOW ANALYZER W/COMPUTER
    K890335 SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
    K890333 ALBUMIN REAGENT
    K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER
    K860367 MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
    K851990 INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
    Search all 33 clearances from Alpkem Corp. →