| Device Type ID | 451 |
| Device Name | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Regulation Description | Continuous Flow Sequential Multiple Chemistry 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 | 862.2150 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 451 |
| Device | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Product Code | JJC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Continuous Flow Sequential Multiple Chemistry Analyzer For Clinical Use. |
| CFR Regulation Number | 862.2150 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 10 |
Incorrect Or Inadequate Test Results | 8 |
High Test Results | 7 |
Port | 2 |
Device Emits Odor | 2 |
Device Issue | 1 |
Device Subassembly | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 32 |