Device Type ID | 623 |
Device Name | System, Test, Sodium, Enzymatic Method |
Regulation Description | Sodium 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) |
CFR Regulation Number | 862.1665 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MZU |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |