FDA 510(k)

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

Número K: K192727 · 2020-05-20

Data da decisão2020-05-20

Código do produtoDHR

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Company. It received FDA 510(k) clearance on 2020-05-20 under 510(k) number K192727. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is a medical device that received FDA 510(k) clearance on 2020-05-20. The listed applicant is Kamiya Biomedical Company. The 510(k) number is K192727.

When did K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) receive FDA 510(k) clearance?

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) received FDA 510(k) clearance on 2020-05-20, under 510(k) number K192727.

Who is the listed applicant for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?

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

What is the FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)?

The FDA product code for K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) is DHR.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: DHR)

K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia AB K162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.