FDA product code · Immunology

C3-Indirect Immunofluorescent Solid Phase

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

KTMClass II21 CFR 866.5240510(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 KTM 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 — KTM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KTM? 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 866.5240.

CZW Complement C3, Antigen, Antiserum, Control DAE Complement C9, Antigen, Antiserum, Control DAG Complement C8, Antigen, Antiserum, Control DBI Complement C4, Antigen, Antiserum, Control CZY Complement C1s, Antigen, Antiserum, Control DAI Complement C1r, Antigen, Antiserum, Control DAY Complement C5, Antigen, Antiserum, Control DAK Complement C1q, Antigen, Antiserum, Control