DCEClass I

Fab, Antigen, Antiserum, Control

21 CFR 866.5520 / Immunology

DCE is the FDA product code for Fab, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5520. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1979-02-16, and no recalls.

Classification record

Product code: DCE
Device name: Fab, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5520
Device class: Class I
Review panel: Immunology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code DCE

By decision year

2 clearances under product code DCE with a decision year between 1977 and 1979, 1977 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code DCE by decision year
Year	Clearances
1977	1
1979	1

Applicants with the most clearances

Product code DCE

Applicants holding the most 510(k) clearances under product code DCE
Applicant	Clearances
Kallestad Laboratories, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DCE.

Recent clearances

Product code DCE

Recent recalls

Product code DCE

FDA records show no recalls under product code DCE.

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)