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FDA 510(k)

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

N.º K: K193393 · 2020-03-06

SolicitanteLeica Biosystems Newcastle, Ltd.
Fecha de decisión2020-03-06
Código de productoMXZ
Comité asesorHE
DecisiónSubstantially Equivalent

Resumen del dispositivo

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Newcastle, Ltd.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K193393. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Leica Biosystems Newcastle, Ltd.. The 510(k) number is K193393.

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

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). received FDA 510(k) clearance on 2020-03-06, under 510(k) number K193393.

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

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

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

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

Ensayos clínicos relacionados

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Otros registros que enlistan a Leica Biosystems Newcastle, Ltd. como solicitante

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.

K213348BOND MMR Antibody Panel

Dispositivos relacionados (Código: MXZ)

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.

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/SK171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16Leica Biosystems Newcastle, LimitedK160922FLEX 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.

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.

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