| Device Type ID | 2269 | 
| Device Name | Test, Leukocyte Alkaline Phosphatase | 
| Regulation Description | Leukocyte Alkaline Phosphatase Test. | 
| Regulation Medical Specialty | Hematology | 
| Review Panel | Hematology | 
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health  (OIR) | 
| Submission Type | 510(K) Exempt | 
| CFR Regulation Number | 864.7660 [🔎] | 
| FDA Device Classification | Class 1 Medical Device | 
| Product Code | GHD | 
| GMP Exempt | No | 
| Summary MR | Eligible | 
| Implanted Device | No | 
| Life Support Device | No | 
| Third Party Review | Not Third Party Eligible | 
| Device Type ID | 2269 | 
| Device | Test, Leukocyte Alkaline Phosphatase | 
| Product Code | GHD | 
| FDA Device Classification | Class 1 Medical Device | 
| Regulation Description | Leukocyte Alkaline Phosphatase Test. | 
| CFR Regulation Number | 864.7660 [🔎] |