| Device Type ID | 456 |
| Device Name | Analyzer, Enzyme, For Clinical Use |
| Regulation Description | Enzyme Analyzer For Clinical 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 | 862.2500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 456 |
| Device | Analyzer, Enzyme, For Clinical Use |
| Product Code | JJI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Enzyme Analyzer For Clinical Use. |
| CFR Regulation Number | 862.2500 [🔎] |
| Device Problems | |
|---|---|
Computer Software Problem | 1 |
Incorrect Software Programming Calculations | 1 |
Programming Issue | 1 |
| Total Device Problems | 3 |