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

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories 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 IDBK140112
510k NumberBK140112
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
ClassificationInstrumentation For Clinical Multiplex Test Systems
Applicant Bio-Rad Laboratories 6565 185th Ave Ne clinical Diagnostics Group Redmond,  WA  98052
Product CodeNSU  
CFR Regulation Number862.2570 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-31
Decision Date2015-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847865002820 BK140112 000
00847865002813 BK140112 000
00847865002592 BK140112 000
03610520505915 BK140112 000
03610520010167 BK140112 000
03610520010150 BK140112 000
03610520540695 BK140112 000
03610520540633 BK140112 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.