OXALATE REAGENT
Device Facts
| Record ID | K883525 |
|---|---|
| Device Name | OXALATE REAGENT |
| Applicant | Sigma Chemical Co. |
| Product Code | LPW · Clinical Chemistry |
| Decision Date | Oct 25, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1542 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.
