NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)— 510(k) K061360

Name: FDA 510(k) clearance K061360
Creator: U.S. Food and Drug Administration
Published: 2006-06-27

Substantially Equivalent

Lab Vision Corp.

FDA 510(k) clearance K061360 for NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1), Substantially Equivalent on 2006-06-27. Applicant: Lab Vision Corp.. Device class: 2.

Clearance details

Applicant: Lab Vision Corp.
Product code: Code MYA
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2006-05-16
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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