CREATINE KINASE-MB (CK-MB) REAGENT SET
Device Facts
| Record ID | K915709 |
|---|---|
| Device Name | CREATINE KINASE-MB (CK-MB) REAGENT SET |
| Applicant | Tech Intl. Co. |
| Product Code | CGS · Clinical Chemistry |
| Decision Date | Jan 27, 1992 |
| 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.
