FDA 510(k)

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

N.º K: K161646 · 2016-11-04

Fecha de decisión2016-11-04

Código de productoCGN

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161646. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Diazyme Laboratories. The 510(k) number is K161646.

When did Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set receive FDA 510(k) clearance?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161646.

Who is the listed applicant for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

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

What is the FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

The FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is CGN.

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 Diazyme Laboratories como solicitante

K172992Diazyme EZ Vitamin D Assay K163418Diazyme DZ-Lite Total beta-hCG Test System K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: CGN)

K233060Elecsys Folate IIIRoche Diagnostics K223590Access Ácido FólicoBeckman Coulter, Inc.K192586LIAISON® FolatoDiaSorin, Inc.K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, 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.