STERICHEK TOTAL CHLORINE REAGENT STRIPS


Device Classification Name

strip, test, reagent, residuals for dialysate, disinfectant

510(k) Number K001194
Device Name STERICHEK TOTAL CHLORINE REAGENT STRIPS
Original Applicant
ENVIRONMENTAL TEST SYSTEMS, INC.
23575 county rd., #106
elkhart, 
IN 
46514

Original Contact david a morris
Regulation Number 876.5665
Classification Product Code
MSY  
Subsequent Product Code
MSZ  
Date Received 04/12/2000
Decision Date 07/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No