Device Type ID | 463 |
Device Name | Electrode, Ion Selective (non-specified) |
Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
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 | 862.2050 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JJP |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |