PENTRA XLR Performance Studies Protocol for Traditional 510(k)
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- STATUS
- Not Recruiting
Updated on 19 February 2024
Summary
Test the clinical performances of the new hematology instrument Pentra XLR compared to the Pentra DX120, previously FDA cleared for reticulocyte parameters (Clearance K050719).
Description
Test the clinical performances of the new hematology instrument Pentra XLR compared to the Pentra DX120, previously FDA cleared for reticulocyte parameters (Clearance K050719).
Details
| Condition | Reticulocyte Counts |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX3939 |
| Last Modified on | 19 February 2024 |
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