510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180004Unknown

picoAMH ELISA

Ansh Labs, LLC, Webster TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN180004 is the FDA 510(k) clearance record for picoAMH ELISA, a class II device, cleared for Ansh Labs, LLC on under FDA product code QDH (Menopause Test System). FDA's definition for product code QDH reads: "A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women". FDA records list one 510(k) clearance for Ansh Labs, LLC. As of , FDA records show no recalls naming DEN180004.

Clearance record

Decision date
Received
(275 days to decision)
Product code
QDH Menopause Test System
Regulation
21 CFR 862.1093
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ansh Labs, LLC 445 Medical Center Blvd., Webster TX
Third party review
No

Clearances, product code QDH

Trailing 12 months

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

FDA records show no clearances under product code QDH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDH, 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