FDA 510(k)

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

N.º K: K251697 · 2025-11-26

Fecha de decisión2025-11-26

Código de productoGTY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K251697. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K251697.

When did Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip receive FDA 510(k) clearance?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip received FDA 510(k) clearance on 2025-11-26, under 510(k) number K251697.

Who is the listed applicant for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

The FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is GTY.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a ACON Laboratories, Inc. como solicitante

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid Test K251749Flowflex Plus RSV + Flu A/B + COVID Home Test K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System K250377Flowflex Plus COVID-19 + Flu A/B Home Test K232715Distinct® Digital Pregnancy Test K233373Flowflex® Plus COVID-19 Home Test

Ver todos los 16 dispositivos →

Dispositivos relacionados (Código: GTY)

K260342Prueba Rápida de Strep A AllTestHangzhou AllTest Biotech Co., Ltd.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.