510(k) Report

FDA product code · Microbiology

Antisera, Neutralization, Rubella

GOJClass II21 CFR 866.3510510(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 GOJ 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 — GOJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GOJ? 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 866.3510.

OPL Multiplex Immunoassay For Measles Virus, Mumps…OMI Multiplex Flow Immunoassay, T. Gondii, Rubella…LSD Rubella, Other AssaysPUQ Multiplex Flow Immunoassay, T. Gondii…OPM Multiplex Immunoassay For T. Gondii, Rubella…GON Antigen, Cf (Including Cf Control), RubellaGOK Antisera, Hai (Including Hai Control), RubellaLFX Enzyme Linked Immunoabsorbent Assay, RubellaGOM Antisera, Cf, RubellaLQN Latex Agglutination Assay, RubellaGOL Antigen, Ha (Including Ha Control), RubellaLSJ Antigen, Rubella, Other