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FDA 510(k)

FLEX 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)

K-Number: K160922 · 2016-05-03

ApplicantDako North America, Inc.
Decision Date2016-05-03
Product CodeMXZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLEX 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) is a medical device manufactured by Dako North America, Inc.. It received FDA 510(k) clearance on 2016-05-03 under approval number K160922. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX 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)?

FLEX 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) is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Dako North America, Inc.. The 510(k) number is K160922.

When was FLEX 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) approved by the FDA?

FLEX 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) received FDA 510(k) clearance on 2016-05-03, under approval number K160922.

What company makes FLEX 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)?

FLEX 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) is manufactured by Dako North America, Inc..

What is the FDA product code for FLEX 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)?

The FDA product code for FLEX 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) is MXZ.

Related Clinical Trials

NCT06086704 Study of 18F-FFNP Breast PET/MRI RECRUITING NCT07593209 First-in-Human Study of the Radioligand 68Ga- DOTA-EphA2 RECRUITING NCT07571291 DEVELOPMENT OF INNOVATIVE TARGETED LIPOSOMAL FORMULATIONS FOR THE TREATMENT OF INFLAMMATORY DRIVEN PULMONARY FIBROSIS ACTIVE_NOT_RECRUITING NCT07565350 Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts RECRUITING NCT02994433 NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits RECRUITING NCT07162038 Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation RECRUITING

Other Devices by Dako North America, Inc.

PMA P150027Immunohistochemistry assay, antibody, programmed death-ligand 1 PMA P040011Immunohistochemistry antibody assay, c-kit

Related Devices (Code: MXZ)

K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)Dako Denmark A/S K171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16Leica Biosystems Newcastle, Limited K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal AntibodyLeica Biosystems Newcastle, Limited 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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