VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)— 510(k) K122556

Name: FDA 510(k) clearance K122556
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Substantially Equivalent

Leica Biosystems Newcastle, Ltd.

FDA 510(k) clearance K122556 for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11), Substantially Equivalent on 2014-05-19. Applicant: Leica Biosystems Newcastle, Ltd.. Device class: 2.

Clearance details

Applicant: Leica Biosystems Newcastle, Ltd.
Product code: Code MYA
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2012-08-22
Decision date: 2014-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, IL, US

Download summary PDF View on FDA.gov ↗

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