Device product
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0516-2014
Product summary
- Event
- Event 66894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84561 kits
- Official record key
device-enforcement:Z-0516-2014
Official wording
Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Code information: All lots
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval