Device Classification Name |
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
|
510(k) Number |
K001194 |
Device Name |
STERICHEK TOTAL CHLORINE REAGENT STRIPS |
Applicant |
ENVIRONMENTAL TEST SYSTEMS, INC. |
23575 COUNTY RD., #106 |
ELKHART,
IN
46514
|
|
Applicant Contact |
DAVID A MORRIS |
Correspondent |
ENVIRONMENTAL TEST SYSTEMS, INC. |
23575 COUNTY RD., #106 |
ELKHART,
IN
46514
|
|
Correspondent Contact |
DAVID A MORRIS |
Regulation Number | 876.5665
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|