| Device Type ID | 2412 |
| Device Name | Assay, Bart's, Hemoglobin |
| Regulation Description | Whole Blood Hemoglobin Assays. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LGL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |