KODAK EKTACHEM DT SLIDES (CHE)
Device Facts
| Record ID | K913198 |
|---|---|
| Device Name | KODAK EKTACHEM DT SLIDES (CHE) |
| Applicant | Eastman Kodak Company |
| Product Code | DIH · Clinical Toxicology |
| Decision Date | Aug 26, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
