Atida Fentanyl Test
Model U02ST-FYL-US · ACESO LABORATORIES INC. · DI 00810164510099
NGL — Test, Opiates, Over The Counter · Class II · 21 CFR 862.3650
UDILibrary device dossier · generated 2026-09-12 · 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
- K233417 SESE 2023-10-26 (k number procode)
Predicate lineage
K233417 — cites (transitively): K231698 (d1), K220046 (d2), K180427 (d3), K973547 (d3), K161216 (d4), K150606 (d5), K040316 (d6), K993755 (d6) — cited as predicate by K234006, K240295, K240351, K240654, K240949, K241741, K241969, K242802
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ACESO LABORATORIES INC.
Nothing in the loaded window.