| Device Type ID | 327 |
| Device Name | Methylthymol Blue, Calcium |
| Regulation Description | Calcium 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 | 862.1145 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CIA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 327 |
| Device | Methylthymol Blue, Calcium |
| Product Code | CIA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Calcium Test System. |
| CFR Regulation Number | 862.1145 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 2 |
Incorrect Or Inadequate Test Results | 1 |
Probe | 1 |
Low Test Results | 1 |
Nozzle Tip | 1 |
| Total Device Problems | 6 |