FDA 510(k)

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

K-Nummer: K252259 · 2025-08-15

Entscheidungsdatum2025-08-15

ProduktcodeNFT

BeratungsausschussTX

EntscheidungSubstantially Equivalent

Produktübersicht

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K252259. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Assure Tech., LLC. The 510(k) number is K252259.

When did AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup receive FDA 510(k) clearance?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2025-08-15, under 510(k) number K252259.

Who is the listed applicant for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

The FDA 510(k) record lists Assure Tech., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is NFT.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Assure Tech., LLC als Antragsteller

K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

Alle 7 Geräte anzeigen →

Verwandte Geräte (Code: NFT)

K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.