AllSource
Model ALLDTHR · Guangzhou Decheng Biotechnology Co., LTD · DI 00850054867629
NFW — Test, Cannabinoid, Over The Counter · Class II · 21 CFR 862.3870
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K232659 — cites (transitively): K201630 (d1), K181768 (d2), K182123 (d2), K122809 (d3) — cited as predicate by K240686, K240698, K250067
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Guangzhou Decheng Biotechnology Co., LTD
Nothing in the loaded window.