BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    TOXOGEN

    K Number: K913467 · Decision Jan 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    16
    Review Days
    525

    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
    TOXOGEN
    K Number
    K913467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biokit USA, Inc.
    Date Received
    August 5, 1991
    Decision Date
    January 11, 1993
    Product Code
    LLA
    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
    LLA Direct Agglutination Test, Toxoplasma Gondii

    Similar 510(k) Clearances

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

    QUIK-DOT TOXOPLASMOSIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TOXOSCAN CARD TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TOXO-SCREEN DA TEST

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

    Other Clearances by Biokit USA, Inc.

    K Number Device Name
    K910541 BIOKIT RPR
    K904310 RHEUMAGEN RF T-CONTROL
    K910539 RHEUMAJET RF
    K910686 RHEUMAJET CRP
    K904311 RHEUMAGEN ASO T-CONTROL
    K904312 RHEUMAGEN CRP T-CONTROL
    K896433 MODIFIED RUBAGEN
    K896271 QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
    K896272 QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
    K894486 QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
    Search all 16 clearances from Biokit USA, Inc. →