DeviceClearance

Product code JPH— Hematology

DADE ESR KIT

Classification name
Test, Erythrocyte Sedimentation Rate
Device class
Class 1
Regulation
21 CFR 864.6700
Advisory panel
Hematology
Total cleared
7
First cleared
Most recent

Market context for product code JPH

FDA has cleared 7 devices under product code JPH between 1982 and 1987, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code JPH

Recent clearances under product code JPH

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