Device Type ID | 4761 |
Device Name | Test, Leukocyte Peroxidase |
Regulation Description | Leukocyte Peroxidase Test. |
Regulation Medical Specialty | Hematology |
Review Panel | Pathology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.7675 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | GIA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4761 |
Device | Test, Leukocyte Peroxidase |
Product Code | GIA |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Leukocyte Peroxidase Test. |
CFR Regulation Number | 864.7675 [🔎] |
Device Problems | |
---|---|
Mechanical Jam | 1 |
Mechanics Altered | 1 |
Failure To Fire | 1 |
Total Device Problems | 3 |