510(k) Premarket Notification Database
Device Classification Name |
enzyme linked immunoabsorbent assay, toxoplasma gondii
|
510(k) Number | K903968 |
Device Name | TOXO-CUBE |
Applicant |
DIFCO LABORATORIES, INC.
|
1180 ellsworth rd. |
ann arbor,
MI
48104 |
|
Contact | walter fischer |
Regulation Number | 866.3780 |
Classification Product Code |
|
Date Received | 08/28/1990 |
Decision Date | 12/18/1990 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|