510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170019Unknown

Vitamin D 200M Assay for the Topaz System

AB Sciex, LLC, Framingham MA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN170019 is the FDA 510(k) clearance record for Vitamin D 200M Assay for the Topaz System, a class II device, cleared for Ab Sciex, LLC on under FDA product code PSL (25-Oh-Vitamin D Mass Spectrometry Test System). FDA's definition for product code PSL reads: "A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry". FDA records list one 510(k) clearance for Ab Sciex, LLC. As of , FDA records show no recalls naming DEN170019.

Clearance record

Decision date
Received
(59 days to decision)
Product code
PSL 25-Oh-Vitamin D Mass Spectrometry Test System
Regulation
21 CFR 862.1840
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ab Sciex, LLC 500 Old Connecticut Path, Framingham MA
Third party review
No

Clearances, product code PSL

Trailing 12 months

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

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