DFSClass II

Igm, Fitc, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology

DFS is the FDA product code for Igm, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1983-07-19, and no recalls.

Classification record

Product code: DFS
Device name: Igm, Fitc, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5550
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code DFS

By decision year

1 clearance under product code DFS with a decision year between 1983 and 1983, 1983 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code DFS by decision year
Year	Clearances
1983	1

Applicants with the most clearances

Product code DFS

Applicants holding the most 510(k) clearances under product code DFS
Applicant	Clearances
Dako Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code DFS

K831907Class IIRabbit Antiserum to Human IgmDako Corp. / cleared 1983-07-19

Recent recalls

Product code DFS

FDA records show no recalls under product code DFS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)