FDA product code · Clinical toxicology

Test, Occult Blood, Over The Counter

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

NGKClass II21 CFR 864.6550510(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, clinical toxicology panel

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

Planning a device in NGK? 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 864.6550.

JIP Blood, Occult, Enzymatic Method, In Urine OSL Control, Fecal Occult Blood OOX Automated Occult Blood Analyzer GGG Guaiac Reagent JIO Blood, Occult, Colorimetric, In Urine KHE Reagent, Occult Blood