510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQOClass II

Anti-Müllerian Hormone Test System

21 CFR 862.1092 / Clinical Chemistry
FDA source (opens on fda.gov)

PQO is the FDA product code for Anti-Müllerian Hormone Test System, a class II device type, regulated under 21 CFR 862.1092. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PQO
Device name
Anti-Müllerian Hormone Test System
FDA 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.
Regulation
21 CFR 862.1092
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code PQO

By decision year
5 clearances under product code PQO with a decision year between 2016 and 2023, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PQO by decision year
YearClearances
20161
20171
20221
20232

Applicants with the most clearances

Product code PQO
Applicants holding the most 510(k) clearances under product code PQO
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Roche Diagnostics GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code