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

    IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

    K Number: K020583 · Decision Sep 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    208

    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
    IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
    K Number
    K020583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ivd Research, Inc.
    Date Received
    February 21, 2002
    Decision Date
    September 17, 2002
    Product Code
    MHI
    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
    MHI Giardia Spp.

    Similar 510(k) Clearances

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

    UNIGOLD GIARDIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

    FDA 510(k)
    FDA Class 2 ·Microbiology

    XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

    FDA 510(k)
    FDA Class 2 ·Microbiology

    XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GIARDIA II

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

    Other Clearances by Ivd Research, Inc.

    K Number Device Name
    K081064 GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
    K032897 C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96
    K031059 IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
    K024113 IVD CRYPTO/GIARDIA DFA