FDA Product Code OVY: Liquid Chemical Processing System
The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring.
Leading manufacturers include STERIS Corporation.
4
Total
3
Cleared
112d
Avg days
2012
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Liquid Chemical Processing System Devices (Product Code OVY)
4 devices
Cleared
Dec 15, 2023
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
STERIS Corporation
General Hospital
29d
Cleared
Sep 11, 2023
VERIFY Spore Test Strip for S40 Sterilant Concentrate
STERIS Corporation
General Hospital
88d
Cleared
May 29, 2018
VERIFY Spore Test Strip for S40 Sterilant
STERIS Corporation
General Hospital
89d
Not Cleared
Mar 30, 2012
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
STERIS Corporation
General Hospital
242d
About Product Code OVY - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OVY since 2012, with 3 receiving FDA clearance (average review time: 112 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.