Home / 510(k) Clearances / K223679

510(k) K223679

Access AMH by Beckman Coulter, Inc. — Product Code PQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2023
Date Received
December 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Müllerian Hormone Test System
Device Class
Class II
Regulation Number
862.1092
Review Panel
TX
Submission Type

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.

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Other clearances for product code PQO

  • K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH) (June 2, 2023)
  • K203757 — Elecsys AMH (June 10, 2022)
  • K170524 — Access AMH (November 13, 2017)
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