510(k) K241344

MetriCide™ OPA Plus Solution Test Strip by Steris — Product Code JOJ

K241344 is an FDA 510(k) premarket notification submitted by Steris for the device "MetriCide™ OPA Plus Solution Test Strip". The FDA issued a decision of Substantially Equivalent on June 11, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2024
Date Received
May 13, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type