| Device Type ID | 474 |
| Device Name | Radioimmunoassay, C-peptides Of Proinsulin |
| Regulation Description | C-peptides Of Proinsulin 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) Exempt |
| CFR Regulation Number | 862.1135 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JKD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 474 |
| Device | Radioimmunoassay, C-peptides Of Proinsulin |
| Product Code | JKD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | C-peptides Of Proinsulin Test System. |
| CFR Regulation Number | 862.1135 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 1 |
Insufficient Information | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Jun-26-2015 |
| 2 | Tosoh Bioscience Inc | II | Jun-05-2018 |