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

    REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

    K Number: K990825 · Decision Apr 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    343
    Review Days
    35

    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
    REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
    K Number
    K990825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Behring, Inc.
    Date Received
    March 12, 1999
    Decision Date
    April 16, 1999
    Product Code
    DCN
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DCN System, Test, C-Reactive Protein

    Similar 510(k) Clearances

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

    CardioPhase® hsCRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    RCRP Flex reagent cartridge

    FDA 510(k)
    FDA Class 2 ·Immunology

    Tina-quant C-Reactive Protein IV

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite High Sensitivity C-Reactive Protein Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

    FDA 510(k)
    FDA Class 2 ·Immunology

    MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

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

    Other Clearances by Dade Behring, Inc.

    K Number Device Name
    K093848 PT-MULTI-CALIBRATOR, MODEL OPAT07
    K081161 DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
    K081249 DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
    K071603 DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
    K071597 DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
    K073604 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
    K073561 DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
    K073072 DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
    K073055 DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
    K072965 DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
    Search all 343 clearances from Dade Behring, Inc. →