FDA product code · Microbiology

Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

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

LKCClass II21 CFR 866.3305510(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, microbiology panel

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

Planning a device in LKC? 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 866.3305.

MXJ Enzyme Linked Immunosorbent Assay, Herpes…LGC Enzyme Linked Immunoabsorbent Assay, Herpes…GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2 MYF Enzyme Linked Immunosorbent Assay, Herpes…GQN Antigen, Cf (Including Cf Control)…OQO Herpes Simplex Virus Nucleic Acid…GQO Antisera, Cf, Herpesvirus Hominis 1,2 GQM Antisera, Neutralization, Herpesvirus Hominis