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510(k) K230451

Device
Aptima® Chlamydia trachomatis Assay
Applicant
Hologic, Inc.
510(k) number
K230451
Product code
MKZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-16
Date received
2023-02-21
Regulation
866.3120
Classification name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jon Kukowski
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MKZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140446BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2014-05-20
K110923COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.2012-01-24
K091724BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-11-13
K090824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-06-02
K081824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2008-12-11
K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITAbbott Molecular, Inc.2008-07-10
K070174AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORYRoche Diagnostics Corporation2007-04-16
K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199Gen-Probe, Inc.2007-01-22
K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMGen-Probe, Inc.2006-10-13
K053287COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Diagnostics Corp.2006-08-10
K053446GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088Gen-Probe, Inc.2006-07-25
K043072GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATISGen-Probe, Inc.2005-01-27
K973707ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Molecular Systems, Inc.1999-08-04
K973718ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Molecular Systems, Inc.1998-12-15
K964507ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TESTRoche Molecular Systems, Inc.1997-06-13