BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HAEMOPHILUS ISOLATION AGAR 2827

    K Number: K841673 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    306
    Applicant Total
    67
    Review Days
    28

    Basic Information

    Device Name
    HAEMOPHILUS ISOLATION AGAR 2827
    K Number
    K841673
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
    Date Received
    April 23, 1984
    Decision Date
    May 21, 1984
    Product Code
    JSJ
    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
    JSJ Culture Media, Selective And Non-Differential

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.

    POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MYCOLOGICAL AGAR W/LOW PH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BRILLIANT GREEN AGAR W/SULFADIAZINE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    W-L DIFFERENTIAL MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INHIBITORY MOLD AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LITTMAN AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.

    K Number Device Name
    K871855 SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
    K871541 MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
    K870134 MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
    K864755 PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
    K864014 LOMBARD DOWELL AGAR BASE
    K863821 MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
    K863820 DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
    K863289 CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
    K862425 MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
    K861058 SENSITITRE AUTO ID PLATE, AP70
    Search all 67 clearances from GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. →