DeviceClearance

Product code SHB— Clinical Chemistry

Nova Max Creat eGFR Monitoring System

Classification name
Creatinine Test System For At Home Prescription Use
Device class
Class 2
Regulation
21 CFR 862.1225
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SHB under 21 CFR 862.1225, via openFDA

Market context for product code SHB

FDA has cleared 1 device under product code SHB, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHB

Recent clearances under product code SHB

Data sourced from openFDA. This site is unofficial and independent of the FDA.