Elecsys AMH

FDA 510(k) K203757 · Roche Diagnostics

Substantially Equivalent

510(k) numberK203757

Submission

Device name
Elecsys AMH
Applicant
Roche Diagnostics
Indianapolis, IN, US
Received
December 23, 2020
Decision date
June 10, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PQO – Anti-Müllerian Hormone Test System
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1092
Specialty
Clinical Chemistry

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.

Other 510(k)s with product code PQO

510(k)DeviceApplicantDecision
K221801ADVIA Centaur® Anti-Müllerian Hormone (AMH)PQO · Traditional Siemens Healthcare Diagnostics, Inc.06/02/2023SE
K223679Access AMHPQO · Traditional Beckman Coulter, Inc.02/03/2023SE
K170524Access AMHPQO · Traditional Beckman Coulter, Inc.11/13/2017SE

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Questions and answers

When was Elecsys AMH cleared by the FDA?

Elecsys AMH (K203757) received a 510(k) decision of Substantially Equivalent on June 10, 2022, 534 days after the submission was received.

What is the product code of K203757?

The FDA product code is PQO – Anti-Müllerian Hormone Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1092.