| Device Type ID | 424 |
| Device Name | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Regulation Description | Creatine Phosphokinase/creatine Kinase 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 | 862.1215 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JHS |
| 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 | 424 |
| Device | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Product Code | JHS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System. |
| CFR Regulation Number | 862.1215 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 1 |
High Test Results | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc | II | Oct-15-2018 |