DeviceClearance

Product code DCF— Immunology

QM300 ALBUMIN ANTIBODY PACK

Classification name
Albumin, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5040
Advisory panel
Immunology
Total cleared
37
First cleared
Most recent

Market context for product code DCF

FDA has cleared 37 devices under product code DCF between 1977 and 2016, filed by 27 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 DCF

Recent clearances under product code DCF

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