FDA 510(k)

N Latex FLC kappa, N Latex FLC lambda

N.º K: K201496 · 2021-10-29

SolicitanteSiemens Healthcare Diagnostics Products GmbH

Fecha de decisión2021-10-29

Código de productoDFH

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

N Latex FLC kappa, N Latex FLC lambda is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K201496. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the N Latex FLC kappa, N Latex FLC lambda?

N Latex FLC kappa, N Latex FLC lambda is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K201496.

When did N Latex FLC kappa, N Latex FLC lambda receive FDA 510(k) clearance?

N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2021-10-29, under 510(k) number K201496.

Who is the listed applicant for N Latex FLC kappa, N Latex FLC lambda?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N Latex FLC kappa, N Latex FLC lambda?

The FDA product code for N Latex FLC kappa, N Latex FLC lambda is DFH.

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 Siemens Healthcare Diagnostics Products GmbH como solicitante

K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)K220728vWF Ag K212559CardioPhase® hsCRP K212379N Latex FLC kappa, N Latex FLC lambda K193047N Latex FLC kappa, N Latex FLC lambda

Ver todos los 18 dispositivos →

Dispositivos relacionados (Código: DFH)

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

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.