Device Type ID | 273 |
Device Name | 2,4-dinitrophenylhydrazine, Lactate Dehydrogenase |
Regulation Description | Lactate Dehydrogenase Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Clinical Chemistry |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 862.1440 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CER |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |