Device Classification Name |
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
More FDA Info for this Device |
510(K) Number |
K001194 |
Device Name |
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
Applicant |
ENVIRONMENTAL TEST SYSTEMS, INC.
23575 COUNTY RD., #106
ELKHART, IN 46514 US
Other 510(k) Applications for this Company
|
Contact |
DAVID A MORRIS
Other 510(k) Applications for this Contact |
Regulation Number |
876.5665
More FDA Info for this Regulation Number |
Classification Product Code |
MSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/12/2000 |
Decision Date |
07/11/2000 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
GU - Gastroenterology & Urology |
Review Advisory Committee |
GU - Gastroenterology & Urology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|