CHT · Electrophoretic Method, Catecholamines
Clinical Chemistry · 21 CFR 862.1165 · Class 1
Overview
| Product Code | CHT |
|---|---|
| Device Name | Electrophoretic Method, Catecholamines |
| Regulation | 21 CFR 862.1165 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K913196 | KODAK EKTACHEM DT SLIDES (LIPASE) | Eastman Kodak Company | Sep 25, 1991 | SESE |
| K760920 | CAT-A-KIT | The Upjohn Co. | Nov 9, 1976 | SESE |
Top Applicants
- Eastman Kodak Company — 1 clearance
- The Upjohn Co. — 1 clearance
