DeviceClearance

Product code PQO— Clinical Chemistry

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Classification name
Anti-Müllerian Hormone Test System
Device class
Class 2
Regulation
21 CFR 862.1092
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PQO under 21 CFR 862.1092, via openFDA

Market context for product code PQO

FDA has cleared 5 devices under product code PQO between 2016 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQO

Recent clearances under product code PQO

Data sourced from openFDA. This site is unofficial and independent of the FDA.