Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

Número K: K171753 · 2017-07-21

RequerenteLeica Biosystems Newcastle, Limited
Data da decisão2017-07-21
Código do produtoMXZ
Comité consultivoHE
DecisãoSubstantially Equivalent

Resumo do dispositivo

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Newcastle, Limited. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171753. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16?

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Leica Biosystems Newcastle, Limited. The 510(k) number is K171753.

When did BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 receive FDA 510(k) clearance?

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171753.

Who is the listed applicant for BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16?

The FDA 510(k) record lists Leica Biosystems Newcastle, Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16?

The FDA product code for BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 is MXZ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Leica Biosystems Newcastle, Limited como candidato(a)

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.

K183100Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraK183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody

Dispositivos Relacionados (Código: MXZ)

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.

K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).Leica Biosystems Newcastle, Ltd.K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal AntibodyLeica Biosystems Newcastle, LimitedK170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)Dako Denmark A/SK160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)Dako North America, Inc.

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.

↑