FDA Product Code GMZ: Antigens, All Types, Escherichia Coli
Leading manufacturers include Meridian Bioscience, Inc..
14
Total
14
Cleared
167d
Avg days
1989
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Antigens, All Types, Escherichia Coli Devices (Product Code GMZ)
14 devices
About Product Code GMZ - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code GMZ since 1989, with 14 receiving FDA clearance (average review time: 167 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
GMZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →