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

    REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT

    K Number: K920397 · Decision Aug 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    107
    Review Days
    187

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    Basic Information

    Device Name
    REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
    K Number
    K920397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    January 30, 1992
    Decision Date
    August 4, 1992
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

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    Other Clearances by Medical Analysis Systems, Inc.

    K Number Device Name
    K042717 MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
    K041194 ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
    K040880 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
    K032826 MAS PAR TDM
    K032335 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
    K031890 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
    K031441 URICHEMTRAK LIQUID ASSAYED URINE CONTROL
    K031392 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
    K031364 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
    K030942 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
    Search all 107 clearances from Medical Analysis Systems, Inc. →