Known Identifiers & Locations
FEI Numbers
3002769706
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0043-05 |
The MDA system with MDA Antithrombin III
MDA Heparin
Reason: The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
|
2004-06-11 |
Terminated
|
View Details
|
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