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

    LUMATAG T4 CHEMILUMINESCENCE ASSAY

    K Number: K911985 · Decision Aug 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    12
    Review Days
    88

    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
    LUMATAG T4 CHEMILUMINESCENCE ASSAY
    K Number
    K911985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    London Diagnostics, Inc.
    Date Received
    May 6, 1991
    Decision Date
    August 2, 1991
    Product Code
    CDX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CDX Radioimmunoassay, Total Thyroxine

    Similar 510(k) Clearances

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

    ELECSYS T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE THYROXINE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA NEONATAL THYROXINE KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM(TM) TOTAL T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by London Diagnostics, Inc.

    K Number Device Name
    K914835 LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
    K912858 LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
    K905814 LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
    K904458 LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
    K903130 LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY
    K902443 LUMATAG(TM) LH DIAGNOSTIC KIT
    K903195 LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY
    K901484 LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC
    K901075 LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
    K881443 LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY
    Search all 12 clearances from London Diagnostics, Inc. →