FDA product code · Clinical chemistry

Acid, Uric, Uricase (Gasometric)

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

JHAClass I21 CFR 862.1775510(k) exempt0 decisions0 recalls

FDA lists JHA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 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 chemistry panel

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

Planning a device in JHA? 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 862.1775.

CDO Acid, Uric, Uricase (U.V.)LFQ Acid, Uric, Acid Reduction Of Ferric Ion CDH Acid, Uric, Phosphotungstate Reduction JHC Acid, Uric, Uricase (Oxygen Rate)KNK Acid, Uric, Uricase (Colorimetric)PTC Uric Acid Test System For At Home Prescription…