510(k) K980164

STERICHEK PERACETIC ACID REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code MSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1998
Date Received
January 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type