Device Type ID | 312 |
Device Name | Acid, Phosphoric-tungstic (spectrophotometric), Chloride |
Regulation Description | Chloride 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 | 862.1170 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CHG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |