FDA product code · Immunology

Igg, Rhodamine, Antigen, Antiserum, Control

Name: FDA decisions, review times, recalls and adverse event reports for product code DFO
Creator: 510(k) Report

DFOClass II21 CFR 866.5510510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of DFO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — DFO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DFO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 866.5510.

DGP Ige, Fitc, Antigen, Antiserum, Control PCO Immunoglobulin G Lambda Heavy And Light Chain…CZN Iga, Fitc, Antigen, Antiserum, Control CFQ Radioimmunoassay, Immunoglobulins (G, A, M)DEW Igg, Antigen, Antiserum, Control PDE Immunoglobulin M Kappa Heavy And Light Chain…DAH Gamma Globulin, Antigen, Antiserum, Control PDF Immunoglobulin M Lambda Heavy And Light Chain…MLH Strip, Hama Igg, Elisa, In Vitro Test System CZK Iga, Rhodamine, Antigen, Antiserum, Control DAA Igg, Peroxidase, Antigen, Antiserum, Control DGK Igg, Fitc, Antigen, Antiserum, Control