Elecsys CA-125 II assay— 510(k) K143534

Name: FDA 510(k) clearance K143534
Creator: U.S. Food and Drug Administration
Published: 2015-08-06

Substantially Equivalent

Roche Professional Diagnostics

FDA 510(k) clearance K143534 for Elecsys CA-125 II assay, Substantially Equivalent on 2015-08-06. Applicant: Roche Professional Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Professional Diagnostics
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2014-12-12
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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