FDA product code · Immunology

Immunoglobulin G Lambda Heavy And Light Chain Combined

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

PCOClass II21 CFR 866.5510510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.

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

Planning a device in PCO? 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.