SHBClass II
Creatinine Test System For At Home Prescription Use
21 CFR 862.1225 / Clinical Chemistry
SHB is the FDA product code for Creatinine Test System For At Home Prescription Use, a class II device type, regulated under 21 CFR 862.1225. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SHB
- Device name
- Creatinine Test System For At Home Prescription Use
- FDA 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.
- Regulation
- 21 CFR 862.1225
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SHB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SHB| Applicant | Clearances |
|---|---|
| Nova Biomedical Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SHB.
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