Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)

K-Number: K984567 · 1999-08-12

ApplicantVentana, Inc.
Decision Date1999-08-12
Product CodeMYA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) is the device name listed in this FDA 510(k) record. The listed applicant is Ventana, Inc.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K984567. The device is classified under product code MYA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)?

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Ventana, Inc.. The 510(k) number is K984567.

When did VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) receive FDA 510(k) clearance?

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) received FDA 510(k) clearance on 1999-08-12, under 510(k) number K984567.

Who is the listed applicant for VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)?

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

What is the FDA product code for VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)?

The FDA product code for VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) is MYA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: MYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183100Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraLeica Biosystems Newcastle, LimitedK170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/SK120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIDako North America, Inc.K110215CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc.K081286MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634Dako North America, Inc.K061360NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)Lab Vision Corp.

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.

↑