DeviceClearance

Product code DAA— Immunology

ANA MICROZYME TEST SYS #1610

Classification name
Igg, Peroxidase, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
5
First cleared
Most recent

Market context for product code DAA

FDA has cleared 5 devices under product code DAA between 1979 and 1983, filed by 3 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 DAA

Recent clearances under product code DAA

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