| Device Type ID | 589 |
| Device Name | Enzymatic, Carbon-dioxide |
| Regulation Description | Bicarbonate/carbon Dioxide 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 | 862.1160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KHS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 589 |
| Device | Enzymatic, Carbon-dioxide |
| Product Code | KHS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bicarbonate/carbon Dioxide Test System. |
| CFR Regulation Number | 862.1160 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HITACHI CHEMICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 13 |
Low Test Results | 11 |
Incorrect Or Inadequate Test Results | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Inadequate Storage | 1 |
| Total Device Problems | 27 |