DeviceClearance

Product code DEW— Immunology

QM300 IGG ANTIBODY PACK

Classification name
Igg, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
76
First cleared
Most recent

Market context for product code DEW

FDA has cleared 76 devices under product code DEW between 1976 and 2005, filed by 49 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 DEW

Recent clearances under product code DEW

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