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

    CEDIA T UPTAKE ASSAY

    K Number: K954807 · Decision Dec 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    340
    Review Days
    63

    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
    CEDIA T UPTAKE ASSAY
    K Number
    K954807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    October 19, 1995
    Decision Date
    December 21, 1995
    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

    T-UPTAKE EIA TEST

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

    Other Clearances by Boehringer Mannheim Corp.

    K Number Device Name
    K984326 ELECYS IGE ASSAY
    K983047 ACCU-CHEK HQ SYSTEM
    K984419 ELECSYS IGE CALCHECK
    K984425 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
    K984372 ELECSYS CALCHECK TROPONIN T
    K984105 ELECSYS TROPONIN T STAT TEST
    K983503 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
    K983469 PRECISET SERUM PROTEINS CALIBRATOR
    K983185 BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
    K982949 ELECSYS PSA, MODEL 2010
    Search all 340 clearances from Boehringer Mannheim Corp. →