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FDA 510(k)

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

K-Number: K060227 · 2006-05-25

ApplicantVision Biosystems, Inc.
Decision Date2006-05-25
Product CodeMYA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) is the device name listed in this FDA 510(k) record. The listed applicant is Vision Biosystems, Inc.. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K060227. 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 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)?

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Vision Biosystems, Inc.. The 510(k) number is K060227.

When did VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) receive FDA 510(k) clearance?

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) received FDA 510(k) clearance on 2006-05-25, under 510(k) number K060227.

Who is the listed applicant for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)?

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

What is the FDA product code for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)?

The FDA product code for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) is MYA.

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Other records listing Vision Biosystems, Inc. as applicant

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.

K062615VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16

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

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

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