Product code DDQ— Hematology

ANTITHROMBIN III RIA

Classification name
Antigen, Antiserum, Control, Antithrombin Iii
Device class
Class 2
Regulation
21 CFR 864.7060
Advisory panel
Hematology
Total cleared
4
First cleared
Most recent

Market context for product code DDQ

FDA has cleared 4 devices under product code DDQ between 1978 and 1997, filed by 4 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 DDQ

Recent clearances under product code DDQ

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