Device Classification Name |
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
|
510(k) Number |
K954576 |
Device Name |
AXSYM TOXO IGM |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT MALL |
BUFFALO,
NY
14225
|
|
Applicant Contact |
JOANNE RUPPRECHT |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT MALL |
BUFFALO,
NY
14225
|
|
Correspondent Contact |
JOANNE RUPPRECHT |
Regulation Number | 866.3780
|
Classification Product Code |
|
Date Received | 10/02/1995 |
Decision Date | 08/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|