COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
Device Facts
| Record ID | K872041 |
|---|---|
| Device Name | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM |
| Applicant | Coulter Electronics, Inc. |
| Product Code | JHT · Clinical Chemistry |
| Decision Date | Sep 16, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
