FDA Product Code MKZ: Dna Probe, Nucleic Acid Amplification, Chlamydia
Leading manufacturers include Hologic, Inc..
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
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.
MKZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →