Device Classification Name |
System, Dialysate Delivery, Single Patient
|
510(k) Number |
K964264 |
Device Name |
HIGH RANGE PEROXIDE TEST STRIP |
Applicant |
INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
2931 MOOSE TRAIL |
ELKHART,
IN
46514
|
|
Applicant Contact |
WEN H WU |
Correspondent |
INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
2931 MOOSE TRAIL |
ELKHART,
IN
46514
|
|
Correspondent Contact |
WEN H WU |
Regulation Number | 876.5820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/25/1996 |
Decision Date | 06/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|