| Device Type ID | 350 |
| Device Name | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Regulation Description | Alkaline Phosphatase Or Isoenzymes 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 | 862.1050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CJE |
| 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 | 350 |
| Device | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Product Code | CJE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Alkaline Phosphatase Or Isoenzymes Test System. |
| CFR Regulation Number | 862.1050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RANDOX LABORATORIES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |