Product code NGJ— Clinical Chemistry
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
- Classification name
- Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NGJ
FDA has cleared device under product code NGJ, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code NGJ
Recent clearances under product code NGJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.