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

    READER

    K Number: K926248 · Decision May 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    26
    Review Days
    519

    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
    READER
    K Number
    K926248
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alamar Biosciences Laboratory, Inc.
    Date Received
    December 14, 1992
    Decision Date
    May 17, 1994
    Product Code
    LRH
    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
    LRH Instrument For Auto Reader Of Overnight Microorganism Identification System

    Similar 510(k) Clearances

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

    GRAM NEGATIVE IDENTIFICATION PLUS CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AUTOSCEPTOR IDENTIFICATION SYSTEM

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

    Other Clearances by Alamar Biosciences Laboratory, Inc.

    K Number Device Name
    K941425 ALAMAR ANTIBIOTIC SUSCEPTIBILITY
    K926002 ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
    K925951 READAR
    K930469 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K930055 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K924500 ANTIMICROBIAL SUSCEPTIBILITY TEST
    K922780 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K922003 ANTIMICROBIAL SUSCETIBILITY TEST PANEL
    K922168 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K911558 ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
    Search all 26 clearances from Alamar Biosciences Laboratory, Inc. →