510(k) Report

FDA product code · Hematology

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition

JBIClass II21 CFR 864.7360510(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, hematology panel

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

Planning a device in JBI? 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 864.7360.

JBF Glucose-6-Phosphate Dehydrogenase…JBG Glucose-6-Phosphate Dehydrogenase…JMB Visual, Semi-Quant. (Colorimetric)…KQE Assay, Erythrocytic Glucose-6-Phosphate…JBM Glucose-6-Phosphate Dehydrogenase…JBH Glucose-6-Phosphate Dehydrogenase…JLM Isoenzymes, Electrophoretic…JBL Glucose-6-Phosphate Dehydrogenase…JMC Nadp Reduction (U.V.), Glucose-6-Phosphate…JBK Glucose-6-Phosphate Dehydrogenase…JBJ Glucose-6-Phosphate Dehydrogenase…