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

    IMMPULSE TBC ASSAY REAGENTS

    K Number: K840853 · Decision Apr 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    7
    Review Days
    37

    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
    IMMPULSE TBC ASSAY REAGENTS
    K Number
    K840853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Paragon Diagnostics, Inc.
    Date Received
    February 24, 1984
    Decision Date
    April 1, 1984
    Product Code
    KHQ
    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
    KHQ Radioassay, Triiodothyronine Uptake

    Similar 510(k) Clearances

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

    ACE T UPTAKE REAGENT TU CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T-UPTAKE MICROPLATE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHIRON DIAGNOSTICS ACS:180TU P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS T-UPTAKE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CEDIA T UPTAKE ASSAY

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

    Other Clearances by Paragon Diagnostics, Inc.

    K Number Device Name
    K841161 IMMPULSE AMIKACIN ASSAY REAGENTS
    K841162 IMMPULSE GENTAMICIN ASSAY REAGENTS
    K840852 IMMPULSE T4 ASSAY REAGENTS
    K840758 IMMPULSE THEOPHYLLINE ASSAY REAGENTS
    K840847 IMMPULSE TOBRAMYCIN ASSAY REAGENTS
    K834070 IMMPULSE SYSTEM