BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

    K Number: K053287 · Decision Aug 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    18
    Applicant Total
    264
    Review Days
    258

    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
    COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
    K Number
    K053287
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    November 25, 2005
    Decision Date
    August 10, 2006
    Product Code
    MKZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

    Similar 510(k) Clearances

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

    Aptima® Chlamydia trachomatis Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COBAS 4800 CT / NG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Roche Diagnostics Corp.

    K Number Device Name
    K130138 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
    K101365 ELECSYS CA 19-9 CALCHECK 5
    K100853 COBAS 8000 MODULAR SERIES ANALYZER
    K101196 ACCU-CHEK ULTRFLEX INFUSION SET
    K093664 AMPHETAMINES II ASSAY
    K101075 ELECSYS INSULIN CALCHECK 5
    K093421 ELECSYS TESTOSTERONE II IMMUNOASSAY
    K092848 ELECSYS TROPONIN T CALCHECK 5
    K092940 COAGUCHEK XS PLUS PST SYSTEM
    K093700 ELECSYS HCG STAT CALCHECK 5
    Search all 264 clearances from Roche Diagnostics Corp. →