ONX · Class II · 21 CFR 866.6050

FDA Product Code ONX: Ovarian Adnexal Mass Assessment Score Test System

An Ovarian/adnexal Mass Assessment Test Is A Devicem That Measures One Or More Proteins In Serum. It Yields A Single Result For The Likelihood That An Adnexal Pelvic Mass In A Woman, For Whom Surgery Is Planned, Is Malignant. The Test Isn For Adjunctive Use, In Teh Context Of A Negative Primary Clinical And Radiological Evaluation, To Augmrent The Identification Of Patienets Whose Gynecologic Surgery Requires Oncology Expertise And Resources.

6
Total
5
Cleared
225d
Avg days
2009
Since

FDA 510(k) Cleared Ovarian Adnexal Mass Assessment Score Test System Devices (Product Code ONX)

6 devices
1–6 of 6
No devices found for this product code.

About Product Code ONX - Regulatory Context