SHB — Creatinine Test System For At Home Prescription Use Class II
FDA product code SHB covers "Creatinine Test System For At Home Prescription Use", a Class II medical device regulated under 21 CFR 862.1225. 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
- SHB
- Device Class
- Class II
- Regulation Number
- 862.1225
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251281 | nova biomedical corporation | Nova Max Creat eGFR Monitoring System | January 21, 2026 |