MKZ · Class I · 21 CFR 866.3120

FDA Product Code MKZ: Dna Probe, Nucleic Acid Amplification, Chlamydia

Leading manufacturers include Gen-Probe, Inc., Roche Molecular Systems, Inc. and Becton, Dickinson & CO.

19
Total
19
Cleared
247d
Avg days
1993
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dna Probe, Nucleic Acid Amplification, Chlamydia Devices (Product Code MKZ)

19 devices
1–19 of 19
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451
Hologic, Inc.
Microbiology · 268d
Cleared May 20, 2014
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446
Becton, Dickinson & CO
Microbiology · 88d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Nov 13, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724
Becton, Dickinson & CO
Microbiology · 155d
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824
Becton, Dickinson & CO
Microbiology · 68d
Cleared Dec 11, 2008
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824
Becton, Dickinson & CO
Microbiology · 167d
Cleared Jan 22, 2007
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
K063451
Gen-Probe, Inc.
Microbiology · 68d
Cleared Oct 13, 2006
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
K061413
Gen-Probe, Inc.
Microbiology · 144d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Jul 25, 2006
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
K053446
Gen-Probe, Inc.
Microbiology · 225d
Cleared Jan 27, 2005
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072
Gen-Probe, Inc.
Microbiology · 80d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507
Roche Molecular Systems, Inc.
Microbiology · 217d
Cleared Nov 27, 1996
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217
Gen-Probe, Inc.
Microbiology · 170d
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622
Abbott Laboratories
Microbiology · 802d
Cleared Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906
Roche Molecular Systems, Inc.
Microbiology · 363d

About Product Code MKZ - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code MKZ since 1993, with 19 receiving FDA clearance (average review time: 247 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.