DeviceClearance

Product code JBQ— Hematology

ANTITHROMBIN III ASSAY

Classification name
Antithrombin Iii Quantitation
Device class
Class 2
Regulation
21 CFR 864.7060
Advisory panel
Hematology
Total cleared
56
First cleared
Most recent

Market context for product code JBQ

FDA has cleared 56 devices under product code JBQ between 1977 and 2025, filed by 40 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 JBQ

Recent clearances under product code JBQ

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