510(k) Number |
K760089 |
Device Name |
TEST, IN-VITRO DIAGNOSTIC |
Applicant |
HOFFMANN-LA ROCHE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HOFFMANN-LA ROCHE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Date Received | 06/21/1976 |
Decision Date | 07/20/1976 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|