510(k) Report

FDA product code · Immunology

Ige, Fitc, Antigen, Antiserum, Control

DGPClass II21 CFR 866.5510510(k) required4 decisions since 19840 recalls

4 FDA decisions since 1984. 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 DGP 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.

FDA decisions per year · DGP

FDA has decided no DGP device since 2007.

Median 510(k) review, days · DGP

Too few DGP 510(k)s in any year since 2007 to give a median.

Recalls per year · DGP

No recall names DGP since 2007.

Adverse event reports per year · DGP

No MAUDE report names DGP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DGP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DGP? 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

What has FDA decided in DGP lately?

  • K931224Vidas Total Ige (Ige) AssayBiomerieux Vitek, Inc. · 1993
  • K863327Immpulse Ige Assay ReagentsSclavo, Inc. · 1986
  • K842969Allergenetics Aller-Specific Ige SerumAllergenetics · 1984
  • K842749Fiax Total Ige Test KitIntl. Diagnostic Technology · 1984

All 4 DGP decisions →

Related product codes

Other codes under 21 CFR 866.5510.

PCO Immunoglobulin G Lambda Heavy And Light Chain…CZN Iga, Fitc, Antigen, Antiserum, ControlCFQ Radioimmunoassay, Immunoglobulins (G, A, M)DEW Igg, Antigen, Antiserum, ControlPDE Immunoglobulin M Kappa Heavy And Light Chain…DAH Gamma Globulin, Antigen, Antiserum, ControlPDF Immunoglobulin M Lambda Heavy And Light Chain…DFO Igg, Rhodamine, Antigen, Antiserum, ControlMLH Strip, Hama Igg, Elisa, In Vitro Test SystemCZK Iga, Rhodamine, Antigen, Antiserum, ControlDAA Igg, Peroxidase, Antigen, Antiserum, ControlDGK Igg, Fitc, Antigen, Antiserum, Control