HPL RIA KIT
Device Facts
| Record ID | K863188 |
|---|---|
| Device Name | HPL RIA KIT |
| Applicant | Biotecx Laboratories, Inc. |
| Product Code | JMX · Clinical Chemistry |
| Decision Date | Sep 25, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1515 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.
