510(k) K172472

Micro-MEC 1.8% Glutaraldehyde Monitor Strip by STERIS Corporation — Product Code JOJ

K172472 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Micro-MEC 1.8% Glutaraldehyde Monitor Strip". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has 204 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 17, 2017
Date Received
Aug 15, 2017
Clearance Type
Traditional
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
510(k)