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

    IN VITRO DIAGNOSTIC REAGENT

    K Number: K772096 · Decision Nov 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    29
    Review Days
    15

    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
    IN VITRO DIAGNOSTIC REAGENT
    K Number
    K772096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pcl-Ria, Inc.
    Date Received
    November 7, 1977
    Decision Date
    November 22, 1977
    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 Pcl-Ria, Inc.

    K Number Device Name
    K830526 B-GCG SYSTEM BY RIA
    K822935 THYROID STIMULATING HORMONE
    K823014 DIGOXIN KIT
    K822612 T3 UPTAKE KITS
    K820886 THYROXINE T4 KIT
    K820358 FOLLICLE STIMULATING HORMONE KIT
    K820357 LUTEINIZING HORMONE KIT
    K812666 THYROXINE (T4) 125I
    K810867 FOLLICLE STIMULATING HORMONE (FSH)
    K810852 FOLLICLE STIMULATING HORMONE ANTISERUM
    Search all 29 clearances from Pcl-Ria, Inc. →