Device Type ID | 425 |
Device Name | Chromatographic Separation, Cpk 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 | JHT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |