| Device Type ID | 384 |
| Device Name | Enzymatic Method, Bilirubin |
| Regulation Description | Bilirubin (total Or Direct) 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 | 862.1110 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JFM |
| 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 | 384 |
| Device | Enzymatic Method, Bilirubin |
| Product Code | JFM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bilirubin (total Or Direct) Test System. |
| CFR Regulation Number | 862.1110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RANDOX LABORATORIES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |