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

    GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90

    K Number: K972576 · Decision Jan 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    12
    Review Days
    196

    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
    GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
    K Number
    K972576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accumed Intl., Inc.
    Date Received
    July 10, 1997
    Decision Date
    January 22, 1998
    Product Code
    LQL
    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
    LQL Gram Positive Identification Panel

    Similar 510(k) Clearances

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

    RAPID GRAM-POSITIVE ID SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BBLCRYSTAL GRAM-POSITIVE ID SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VISI-STREP

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

    Other Clearances by Accumed Intl., Inc.

    K Number Device Name
    K984489 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
    K983306 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
    K983310 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
    K983309 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    K983301 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
    K982786 TRACCELL 2000 SLIDE MAPPING SYSTEM
    K964689 TRACCELL 2000 SLIDE MAPPING SYSTEM
    K972756 MODIFICATION OF EST CULTURE SYSTEM II - MYCO
    K965190 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
    K960366 SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
    Search all 12 clearances from Accumed Intl., Inc. →