UNITEST CREATINE KINASE
Device Facts
| Record ID | K782156 |
|---|---|
| Device Name | UNITEST CREATINE KINASE |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | JLB · Clinical Chemistry |
| Decision Date | Mar 2, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1210 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
