Device Classification Name |
Enzyme Linked Immunoabsorbent Assay, Rubella
|
510(k) Number |
K954045 |
Device Name |
AXSYM RUBELLA IGG ANTIBODY ASSAY |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
JOANNE RUPPRECHT |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
JOANNE RUPPRECHT |
Regulation Number | 866.3510
|
Classification Product Code |
|
Date Received | 08/29/1995 |
Decision Date | 09/24/1996 |
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
|
|
|