BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
Device Facts
| Record ID | K934925 |
|---|---|
| Device Name | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR |
| Applicant | Beckman Instruments, Inc. |
| Product Code | JIF · Clinical Chemistry |
| Decision Date | Apr 26, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
