Product code JIM— Clinical Chemistry

CHEMTAB

Classification name
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Device class
Class 2
Regulation
21 CFR 862.1340
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

Market context for product code JIM

FDA has cleared 2 devices under product code JIM between 1979 and 1990, filed by 2 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

Top applicants under product code JIM

Recent clearances under product code JIM

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