510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Instrumentation For Clinical Multiplex Test Systems

BioArray Solutions, Ltd.

The following data is part of a premarket notification filed by Bioarray Solutions, Ltd. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK150270
• 510k Number: BK150270
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Instrumentation For Clinical Multiplex Test Systems
• Applicant: BioArray Solutions, Ltd. 35 Technology Drive suite 100 Warren, NJ 07059
• Product Code: NSU
• CFR Regulation Number: 862.2570 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-22
• Decision Date: 2015-06-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234102236	BK150270	0
10888234102229	BK150270	0