DeviceClearance

Product code DFT— Immunology

ACA IMMUNOGLOBIN M TEST PACK

Classification name
Igm, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5550
Advisory panel
Immunology
Total cleared
33
First cleared
Most recent

Market context for product code DFT

FDA has cleared 33 devices under product code DFT between 1976 and 1998, filed by 28 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 DFT

Recent clearances under product code DFT

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