Device Classification Name |
Antibody Igm,If, Cytomegalovirus Virus
|
510(k) Number |
K933549 |
Device Name |
VIDAS CMV IGM ASSAY |
Applicant |
BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
VICKI ANASTASI |
Correspondent |
BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
VICKI ANASTASI |
Regulation Number | 866.3175
|
Classification Product Code |
|
Date Received | 07/22/1993 |
Decision Date | 08/02/1994 |
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
|
|
|