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Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634

by Dako North America, Inc.

510(k) K081286

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081286 Date8 May 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MYA
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a monoclonal rabbit anti-human estrogen receptor alpha antibody, clone SP1, model M3634. It is an immunohistochemistry antibody assay designed for the detection of estrogen receptor alpha in human tissue samples.

The device is supplied as a reagent for in vitro diagnostic use. It has received FDA 510(k) clearance under product code MYA and is classified as a Class II device. The antibody is intended for use in laboratory settings and is not sterile, single-use, or implantable; storage and handling should follow manufacturer guidelines for reagents.

Other devices from Dako North America, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of this monoclonal rabbit anti-human estrogen receptor alpha antibody?

    This device is an immunohistochemistry antibody assay designed for the detection of estrogen receptor alpha in human tissue samples. It is intended for use in laboratory settings as an in vitro diagnostic reagent to support pathological evaluation of ER status in tissue specimens.

  • How is this antibody supplied and is it sterile or single-use?

    The device is supplied as a reagent for in vitro diagnostic use. It is not sterile, not single-use, and not implantable; it is intended for laboratory handling as a reusable reagent, with storage and handling to follow the manufacturer's guidelines for antibody reagents.

  • What regulatory pathway was used for this device and what is its classification?

    The device received FDA 510(k) clearance under submission K081286 and is classified as a Class II device under product code MYA. The clearance was based on a traditional 510(k) submission demonstrating substantial equivalence to a legally marketed predicate device.