DeviceClearance

Product code DAD— Immunology

HAPTOGLOBIN NEPHELOMETRIC ASSAY

Classification name
Haptoglobin, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5460
Advisory panel
Immunology
Total cleared
18
First cleared
Most recent

Market context for product code DAD

FDA has cleared 18 devices under product code DAD between 1976 and 1999, filed by 18 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 DAD

Recent clearances under product code DAD

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