Product code DAF— Immunology

PRECINORM(R) PROTEIN

Classification name
Gamma Globulin, Fitc, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

Market context for product code DAF

FDA has cleared 1 device under product code DAF, all in 1987, filed by 1 applicant company. 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.

Top applicants under product code DAF

Recent clearances under product code DAF

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