SHB

Creatinine Test System For At Home Prescription Use

Product code

SHB

Device name

Creatinine Test System For At Home Prescription Use

Device class

Class 2

21 CFR

21 CFR 862.1225

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-21.

1 summaries are archived here for direct download.