Device Classification Name |
Reagent, Occult Blood
|
510(k) Number |
K002457 |
Device Name |
!NSURE FECAL OCCULT BLOOD TEST |
Applicant |
ENTERIX INC. |
348 US ROUTE ONE |
FALMOUTH,,
ME
04105
|
|
Applicant Contact |
ROBERT C BRUCE |
Correspondent |
ENTERIX INC. |
348 US ROUTE ONE |
FALMOUTH,,
ME
04105
|
|
Correspondent Contact |
ROBERT C BRUCE |
Regulation Number | 864.6550 |
Classification Product Code |
|
Date Received | 08/10/2000 |
Decision Date | 01/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|