MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI— 510(k) K120663

Name: FDA 510(k) clearance K120663
Creator: U.S. Food and Drug Administration
Published: 2013-02-12

Substantially Equivalent

Dako North America, Inc.

FDA 510(k) clearance K120663 for MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI, Substantially Equivalent on 2013-02-12. Applicant: Dako North America, Inc.. Device class: 2.

Clearance details

Applicant: Dako North America, Inc.
Product code: Code MYA
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2012-03-05
Decision date: 2013-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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