Device Classification Name |
Antisera, Cf, Herpesvirus Hominis 1,2
|
510(k) Number |
K881261 |
Device Name |
BION HSV1-G OR HSV2-G TEST SYSTEM |
Applicant |
BION ENT., LTD. |
674 BUSSE HWY. |
PARK RIDGE,
IL
60068
|
|
Applicant Contact |
EDWARD NOWAKOWSKI |
Correspondent |
BION ENT., LTD. |
674 BUSSE HWY. |
PARK RIDGE,
IL
60068
|
|
Correspondent Contact |
EDWARD NOWAKOWSKI |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 03/24/1988 |
Decision Date | 06/07/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|