FDA 510(k)

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

N.º K: K161258 · 2017-02-03

Fecha de decisión2017-02-03

Código de productoMOB

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K161258. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K161258.

When did NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit receive FDA 510(k) clearance?

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit received FDA 510(k) clearance on 2017-02-03, under 510(k) number K161258.

Who is the listed applicant for NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

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

What is the FDA product code for NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit?

The FDA product code for NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit is MOB.

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 Inova Diagnostics, Inc. como solicitante

K243979Reagente Aptiva APS IgA K223093Reagente Aptiva APS IgG; Reagente Aptiva APS IgM K213403Reagente Esencial Aptiva CTD K200230Reagente para Enfermedad Celíaca IgG Aptiva K193604Reagente Aptiva para Enfermedad Celíaca IgA K192916Kit NOVA Lite DAPI dsDNA Crithidia luciliae

Ver todos los 16 dispositivos →

Dispositivos relacionados (Código: MOB)

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus Scientific K243776Anticuerpos Antineutrofilos Citoplasmáticos (Fijados con Etanol); Anticuerpos Antineutrofilos Citoplasmáticos (Fijados con Formaldehído)Zeus Scientific K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Etanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KG K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB

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.