KODAK EKTACHEM DT SLIDES (LIPASE)
Device Facts
| Record ID | K913196 |
|---|---|
| Device Name | KODAK EKTACHEM DT SLIDES (LIPASE) |
| Applicant | Eastman Kodak Company |
| Product Code | CHT · Clinical Chemistry |
| Decision Date | Sep 25, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1165 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).
