FilmArray 2.0 System

Instrumentation For Clinical Multiplex Test Systems

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray 2.0 System.

Pre-market Notification Details

Device IDK143178
510k NumberK143178
Device Name:FilmArray 2.0 System
ClassificationInstrumentation For Clinical Multiplex Test Systems
Applicant BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
ContactKristen Kanack, Phd
CorrespondentKristen Kanack, Phd
BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
Product CodeNSU  
CFR Regulation Number862.2570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-04
Decision Date2015-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020048 K143178 000
00815381020031 K143178 000
00851458005143 K143178 000
00851458005129 K143178 000
00851458005051 K143178 000
00815381029058 K143178 000
00851458005297 K143178 000

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