OVY — Liquid Chemical Processing System Class II

FDA Device Classification

Classification Details

Product Code
OVY
Device Class
Class II
Regulation Number
880.6887
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

The liquid chemical processing system is intended as a standard method for routine monitoring.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233682steris corporationVERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATEDecember 15, 2023
K231746steris corporationVERIFY Spore Test Strip for S40 Sterilant ConcentrateSeptember 11, 2023
K180553steris corporationVERIFY Spore Test Strip for S40 SterilantMay 29, 2018
DEN110002steris corporationSYSTEM 1E PROCESS BIOLOGICAL MONITORING KITMarch 30, 2012