ROMA (HE4 EIA + ARCHITECT CA 125 II)— 510(k) K103358

Unknown

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K103358 for ROMA (HE4 EIA + ARCHITECT CA 125 II), Unknown on 2011-09-01. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code ONX
Device class: Class 2
Regulation: 21 CFR 866.6050
Advisory panel: Obstetrics/Gynecology
Date received: 2010-11-16
Decision date: 2011-09-01
Decision: Unknown
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.