FDA product code SHB: Creatinine Test System For At Home Prescription Use
SHB is the FDA product code for creatinine test system for at home prescription use. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under SHB, 1 in the last five years. The average 510(k) review took 272 days (median 272); 272 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Creatinine Test System For At Home Prescription Use |
| Device class | Class II |
| Regulation | 21 CFR 862.1225 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for SHB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 272 |
Compare with all 510(k) review times · Search every SHB clearance
Top SHB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corporation | 1 | 2026-01-21 |
Most recent SHB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251281 | Nova Biomedical Corporation | Nova Max Creat eGFR Monitoring System | 2026-01-21 | 272 |
Recalls for SHB devices
openFDA lists no recalls for product code SHB.
Frequently asked questions
What is FDA product code SHB?
SHB is the FDA product code for creatinine test system for at home prescription use. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel.
What device class is SHB?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHB?
Across 1 cleared submissions the average was 272 days from receipt to decision (median 272).
Which companies have the most SHB clearances?
Nova Biomedical Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHB
- Run a recall and safety report across every SHB manufacturer
- Watch product code SHB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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