510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203757Substantially Equivalent

Elecsys AMH

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203757 is the FDA 510(k) clearance record for Elecsys AMH, a class II device, cleared for Roche Diagnostics on under FDA product code PQO (Anti-Müllerian Hormone Test System). FDA's definition for product code PQO 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". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K203757.

Clearance record

Decision date
Received
(534 days to decision)
Product code
PQO Anti-Müllerian Hormone Test System
Regulation
21 CFR 862.1092
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQO

Trailing 12 months

FDA records hold no clearances under product code PQO in the trailing twelve months.

FDA records show no clearances under product code PQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260