| Device Type ID | 427 |
| Device Name | Fluorometric 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 | JHX |
| 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 | 427 |
| Device | Fluorometric Method, Cpk Or Isoenzymes |
| Product Code | JHX |
| 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 | |
RADIOMETER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOMETER MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Incorrect Or Inadequate Test Results | 4 |
Low Test Results | 2 |
High Readings | 2 |
False Positive Result | 2 |
Use Of Device Problem | 1 |
Computer Software Problem | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc | II | Sep-17-2018 |
| 2 | Siemens Healthcare Diagnostics Inc | II | Aug-11-2016 |
| 3 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |