BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    IAFP LOWENSTEIN JENSEN SLANT

    K Number: K872685 · Decision Aug 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    50
    Applicant Total
    29
    Review Days
    35

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    Basic Information

    Device Name
    IAFP LOWENSTEIN JENSEN SLANT
    K Number
    K872685
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    I.A.F. Production, Inc.
    Date Received
    July 7, 1987
    Decision Date
    August 11, 1987
    Product Code
    KZI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KZI Culture Media, Enriched

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    Other Clearances by I.A.F. Production, Inc.

    K Number Device Name
    K872690 IAFP V. AGAR SELECTIVE
    K872676 AFP MIDDLEBROOK 7H10 AGAR SLANT
    K872689 IAFP SABOURAUD DEXTROSE AGAR
    K872691 IAFP UREA AGAR SLANT
    K872688 IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD
    K872675 IAFP MANNITOL NACL
    K872669 IAFP X.L.D. AGAR
    K872683 IAFP BILE ESCULIN AGAR
    K872672 IAFP BILE ESCULIN AZIDE AGAR
    K872684 IAFP CAMPYLOBACTER BLASER
    Search all 29 clearances from I.A.F. Production, Inc. →