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

    TOXOSCAN CARD TEST KIT

    K Number: K850768 · Decision May 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    632
    Review Days
    84

    Basic Information

    Device Name
    TOXOSCAN CARD TEST KIT
    K Number
    K850768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    February 25, 1985
    Decision Date
    May 20, 1985
    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.

    TOXOGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QUIK-DOT TOXOPLASMOSIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TOXO-SCREEN DA TEST

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

    Other Clearances by BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC →