HELENA BIOSTRIP PH
Device Facts
| Record ID | K830979 |
|---|---|
| Device Name | HELENA BIOSTRIP PH |
| Applicant | Helena Laboratories |
| Product Code | CEN · Clinical Chemistry |
| Decision Date | May 5, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1550 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
