FDA Product Code MKZ: Dna Probe, Nucleic Acid Amplification, Chlamydia
Leading manufacturers include Roche Diagnostics Corp., Hologic, Inc. and Abbott Laboratories.
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
Cleared
Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
Hologic, Inc.
Microbiology
268d
Cleared
Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Roche Diagnostics Corp.
Microbiology
258d
Cleared
Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
Abbott Laboratories
Microbiology
802d
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.