ROMA Calculation Tool Using Elecsys Assays— 510(k) K153607

Name: FDA 510(k) clearance K153607
Creator: U.S. Food and Drug Administration
Published: 2016-06-15

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K153607 for ROMA Calculation Tool Using Elecsys Assays, Substantially Equivalent on 2016-06-15. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code ONX
Device class: Class 2
Regulation: 21 CFR 866.6050
Advisory panel: Obstetrics/Gynecology
Date received: 2015-12-17
Decision date: 2016-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONX

view all

K160090 — Lumipulse G ROMA2016-05-16
K151502 — ARCHITECT ROMA2016-04-28
K150588 — OVA1 Next Generation2016-03-18
K103358 — ROMA (HE4 EIA + ARCHITECT CA 125 II)2011-09-01
DEN090004 — OVA1 TEST2009-09-11

More clearances from Roche Diagnostics

view all

K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
K252323 — cobas pulse blood glucose monitoring system2026-06-12
K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260048 — Elecsys Anti-HAV IgM2026-04-07

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