Device Type ID | 2350 |
Device Name | Control, Hemoglobin, Abnormal |
Regulation Description | Abnormal Hemoglobin Assay. |
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 | 864.7415 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | JCM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |