510(k) K001194

STERICHEK TOTAL CHLORINE REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code MSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2000
Date Received
April 12, 2000
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