DeviceClearance

Product code DBI— Immunology

COMPLEMENT C4 NEPHELOMETRIC ASSAY

Classification name
Complement C4, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5240
Advisory panel
Immunology
Total cleared
34
First cleared
Most recent

Market context for product code DBI

FDA has cleared 34 devices under product code DBI between 1977 and 2010, 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 DBI

Recent clearances under product code DBI

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