| Device Type ID | 2491 |
| Device Name | Test, Platelet Antibody |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MYP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2491 |
| Device | Test, Platelet Antibody |
| Product Code | MYP |
| FDA Device Classification | Class 2 Medical Device |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMUCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Insufficient Information | 1 |
Device Ingredient Or Reagent Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 7 |