DeviceClearance

Product code JHJ— Clinical Chemistry

BE-SURE

Classification name
Agglutination Method, Human Chorionic Gonadotropin
Device class
Class 2
Regulation
21 CFR 862.1155
Advisory panel
Clinical Chemistry
Total cleared
96
First cleared
Most recent

Market context for product code JHJ

FDA has cleared 96 devices under product code JHJ between 1977 and 1997, filed by 54 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 JHJ

Recent clearances under product code JHJ

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