Device Type ID | 2329 |
Device Name | Glucose-6-phosphate Dehydrogenase (erythrocytic), Spot |
Regulation Description | Erythrocytic Glucose-6-phosphate Dehydrogenase Assay. |
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 | 864.7360 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | JBG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |