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

    ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)

    K Number: K854017 · Decision Oct 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    12
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)
    K Number
    K854017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Lmd Laboratories
    Date Received
    September 30, 1985
    Decision Date
    October 22, 1985
    Product Code
    KHW
    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
    KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

    Similar 510(k) Clearances

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

    E. HISTOLYTICA QUIK CHEK

    FDA 510(k)
    FDA Class 2 ·Microbiology

    E. HISTOLYTICA II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    E. HISTOLYTICA TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENTAMOEBA TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Lmd Laboratories

    K Number Device Name
    K955345 LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
    K942705 E. COLI 0157 ELISA STOOL ASSAY
    K944871 LMD GIARDIA ANTIGEN DETECTION ASSAY
    K905598 CRYPTOSPORIDIUM ANTIGEN DETECTION
    K904613 TRICHINELLA SEROLOGY MICROTITER ELISA
    K900780 CYSTICERCOSIS SEROLOGICAL REAGENTS
    K890003 GIARDIA STOOL ANTIGEN TEST KIT
    K883720 TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
    K870318 AMEBIASIS ELISA TEST KIT
    K854230 MEBIASIS AGAR GEL DIFFUSION KIT
    Search all 12 clearances from Lmd Laboratories →