IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
Device Facts
| Record ID | K003597 |
|---|---|
| Device Name | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 |
| Applicant | Diagnostic Products Corp. |
| Product Code | LPS · Clinical Chemistry |
| Decision Date | Feb 5, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1377 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.
