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

    REMEL XPECT FLU A&B

    K Number: K131804 · Decision Jul 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    17
    Review Days
    23

    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
    REMEL XPECT FLU A&B
    K Number
    K131804
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remel, Inc.
    Date Received
    June 19, 2013
    Decision Date
    July 12, 2013
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

    Similar 510(k) Clearances

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

    ALERE BINAXNOW INFLUENZA A & B CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SAS FLUALERT A & B, SAS INFLUENZA A TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SOFIA INFLUENZA A+B FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUICK VUE INFLUENZA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUICKVUE INFLUENZA A+B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OSOM INFLUENZA A&B TEST MODEL 190

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

    Other Clearances by Remel, Inc.

    K Number Device Name
    K162620 Remel Spectra ESBL
    K092407 REMEL SPECTRA MRSA
    K072827 RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
    K041951 XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
    K033479 PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
    K031942 XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
    K031965 XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
    K031834 XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
    K031565 XPECT INFLUENZA A/B
    K981391 PAR-ONE
    Search all 17 clearances from Remel, Inc. →