Known Identifiers & Locations
FEI Numbers
1000306472
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-0007-04 |
Calculator/Data Processing Module for Clinical Use
Reason: Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
|
2003-08-12 |
Terminated
|
View Details
|
Profile Disclaimer
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