AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
Device Facts
| Record ID | K001285 |
|---|---|
| Device Name | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | JIF · Clinical Chemistry |
| Decision Date | Jun 2, 2000 |
| 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.
