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

    LDH-L LIQUID ENZYMATIC, KINETIC KIT

    K Number: K810083 · Decision Jan 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    110
    Applicant Total
    19
    Review Days
    15

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    Basic Information

    Device Name
    LDH-L LIQUID ENZYMATIC, KINETIC KIT
    K Number
    K810083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1440
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bio-Analytics Laboratories, Inc.
    Date Received
    January 13, 1981
    Decision Date
    January 28, 1981
    Product Code
    CFJ
    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
    CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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    Other Clearances by Bio-Analytics Laboratories, Inc.

    K Number Device Name
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    K860213 ALBUMIN REAGENT KIT
    K851513 ULTRA-VIOLET BUN REAGENT KIT
    K851514 ULTRA-VIOLET GLUCOSE REAGENT
    K850639 ENZYMATIC ALPHA-AMYLASE REAGENT KIT
    K832771 ERYTHROCYTE TEST
    K832567 ACETAMINOPHEN(PARACETAMOL
    K831414 COLORIMETRIC BUN
    K821934 BIO-CAL OPERATION CHECK KIT
    Search all 19 clearances from Bio-Analytics Laboratories, Inc. →