LPW · System, Test, Oxalate
Clinical Chemistry · 21 CFR 862.1542 · Class 1
Overview
| Product Code | LPW |
|---|---|
| Device Name | System, Test, Oxalate |
| Regulation | 21 CFR 862.1542 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883525 | OXALATE REAGENT | Sigma Chemical Co. | Oct 25, 1988 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
