NGJ — Test, Nitrite, Urinary, Non-Quantitative, Over The Counter Class I
FDA product code NGJ covers "Test, Nitrite, Urinary, Non-Quantitative, Over The Counter", a Class I medical device regulated under 21 CFR 862.1510. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NGJ
- Device Class
- Class I
- Regulation Number
- 862.1510
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K103037 | ind diagnostic | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | April 17, 2012 |