Device Classification Name |
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
|
510(k) Number |
K954301 |
Device Name |
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK RD. D49C |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
MARY SPIEWAK |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK RD. D49C |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
MARY SPIEWAK |
Regulation Number | 866.3175
|
Classification Product Code |
|
Date Received | 08/23/1995 |
Decision Date | 03/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|