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 ID: DEN190032
• Device Name: HemosIL Liquid Anti-Xa
• Classification: Anti-factor Xa Activity Test System, Apixaban
• Applicant: Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730
• Contact: Carol Marble
• Product Code: QLU
• CFR Regulation Number: 864.7295 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Hematology
• Classification Advisory: Hematology
• Type: Direct
• Date Received: 2019-06-25
• Decision Date: 2020-09-17
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195226000054	DEN190032	000
00195226000016	DEN190032	000