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

    ALERE PBP2A TEST

    K Number: K121905 · Decision Jul 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    17
    Review Days
    27

    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
    ALERE PBP2A TEST
    K Number
    K121905
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alere Scarborough, Inc.
    Date Received
    June 29, 2012
    Decision Date
    July 26, 2012
    Product Code
    MYI
    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
    MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

    Similar 510(k) Clearances

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

    MECA XPRESSFISH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ALERE PBP2A SA/CONS CULTURE COLONY TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BINAXNOW PBP2A TEST, MODEL 890-000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MASTALEX -MRSA, MODEL RST501

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OXOID PBP2 1 LATEX AGGLUTINATION TEST

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

    Other Clearances by Alere Scarborough, Inc.

    K Number Device Name
    DEN180014 WOUNDCHEK Bacterial Status
    K190204 ID NOW Influenza A & B 2
    K181853 Alere BinaxNOW Influenza A & B Card 2, Alere Reader
    K173653 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
    K173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
    K173502 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    K171792 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
    K162642 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    K163266 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
    K161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
    Search all 17 clearances from Alere Scarborough, Inc. →