NEOLYNX SCREENING APPLICATION MANAGER
Device Facts
| Record ID | K003584 |
|---|---|
| Device Name | NEOLYNX SCREENING APPLICATION MANAGER |
| Applicant | Micromass, Inc. |
| Product Code | JNB · Clinical Chemistry |
| Decision Date | Mar 19, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1555 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.
