Access AMH
FDA 510(k) K223679 · Beckman Coulter, Inc.
510(k) numberK223679
Submission
- Device name
- Access AMH
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- December 8, 2022
- Decision date
- February 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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.
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Questions and answers
When was Access AMH cleared by the FDA?
Access AMH (K223679) received a 510(k) decision of Substantially Equivalent on February 3, 2023, 57 days after the submission was received.
What is the product code of K223679?
The FDA product code is PQO – Anti-Müllerian Hormone Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1092.