Vitamin D 200M Assay For The Topaz System

25-oh-vitamin D Mass Spectrometry Test System

AB SCIEX LLC

The following data is part of a De Novo classification by Ab Sciex Llc with the FDA for Vitamin D 200m Assay For The Topaz System.

Pre-market Notification Details

DeNovo IDDEN170019
Device Name:Vitamin D 200M Assay For The Topaz System
Classification25-oh-vitamin D Mass Spectrometry Test System
Applicant AB SCIEX LLC 500 Old Connecticut Path Framingham,  MA  01701
ContactShilpa Sharma
Product CodePSL  
CFR Regulation Number862.1840 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
TypePost-NSE
Date Received2017-03-20
Decision Date2017-05-18
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10842365100219 DEN170019 000
00842365100090 DEN170019 000
00842365100106 DEN170019 000
00842365100113 DEN170019 000
10842365100127 DEN170019 000
00842365100137 DEN170019 000
10842365100141 DEN170019 000
10842365100158 DEN170019 000
10842365100165 DEN170019 000
00842365100175 DEN170019 000
00842365100182 DEN170019 000
00842365100199 DEN170019 000
00842365100205 DEN170019 000
00842365100021 DEN170019 000

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