510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PSLClass II

25-Oh-Vitamin D Mass Spectrometry Test System

21 CFR 862.1840 / Clinical Chemistry
FDA source (opens on fda.gov)

PSL is the FDA product code for 25-Oh-Vitamin D Mass Spectrometry Test System, a class II device type, regulated under 21 CFR 862.1840. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PSL
Device name
25-Oh-Vitamin D Mass Spectrometry Test System
FDA definition
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.
Regulation
21 CFR 862.1840
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PSL

By decision year
1 clearance under product code PSL with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PSL by decision year
YearClearances
20171

Applicants with the most clearances

Product code PSL
Applicants holding the most 510(k) clearances under product code PSL
ApplicantClearances
AB Sciex, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code