DeviceClearance

Product code CFR— Clinical Chemistry

OLYMPUS GLUCOSE REAGENT

Classification name
Hexokinase, Glucose
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Total cleared
145
First cleared
Most recent

Market context for product code CFR

FDA has cleared 145 devices under product code CFR between 1976 and 2026, filed by 86 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code CFR

Recent clearances under product code CFR

1–100 of 145

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