Cleared Traditional

ADVIA Centaur? Anti-M?llerian Hormone (AMH)

K221801 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Jun 2023
Decision
346d
Days
Class 2
Risk

About This 510(k) Submission

K221801 is an FDA 510(k) clearance for the ADVIA Centaur? Anti-M?llerian Hormone (AMH), a Anti-m�llerian Hormone Test System (Class II — Special Controls, product code PQO), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on June 2, 2023, 346 days after receiving the submission on June 21, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1092.

Submission Details

510(k) Number K221801 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2022
Decision Date June 02, 2023
Days to Decision 346 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code PQO — Anti-müllerian Hormone Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1092
Definition An Anti-müllerian Hormone Test System Is An In Vitro Diagnostic Device Intended To Measure Anti-müllerian Hormone In Human Serum And Plasma. The Test Is Intended To Be Used As An Aid For Assessing Ovarian Reserve In Women.