HemosIL Liquid Anti-Xa

Anti-factor Xa Activity Test System, Apixaban

Instrumentation Laboratory Co.

The following data is part of a De Novo classification by Instrumentation Laboratory Co. with the FDA for Hemosil Liquid Anti-xa.

Pre-market Notification Details

DeNovo IDDEN190032
Device Name:HemosIL Liquid Anti-Xa
ClassificationAnti-factor Xa Activity Test System, Apixaban
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactCarol Marble
Product CodeQLU  
CFR Regulation Number864.7295 [🔎]
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 BoardHematology
Classification AdvisoryHematology
TypeDirect
Date Received2019-06-25
Decision Date2020-09-17
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195226000054 DEN190032 000
00195226000016 DEN190032 000

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