Device Classification Name |
detector, leak, blood
|
510(k) Number |
K012115 |
Device Name |
SERIM BLOOD LEAK TEST STRIP-2 |
Applicant |
SERIM RESEARCH CORP. |
P.O. BOX 4002 |
ELKHART,
IN
46514 -0002
|
|
Applicant Contact |
PATRICA RUPCHOCK |
Correspondent |
SERIM RESEARCH CORP. |
P.O. BOX 4002 |
ELKHART,
IN
46514 -0002
|
|
Correspondent Contact |
PATRICA RUPCHOCK |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/06/2001 |
Decision Date | 11/30/2001 |
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
|
|
|