JBAIDS PLAGUE DETECTION KIT

Yersinia Spp. Reagents

BIOFIRE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Jbaids Plague Detection Kit.

Pre-market Notification Details

Device IDK131729
510k NumberK131729
Device Name:JBAIDS PLAGUE DETECTION KIT
ClassificationYersinia Spp. Reagents
Applicant BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
ContactCynthia Phillips
CorrespondentCynthia Phillips
BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City,  UT  84108
Product CodeOIH  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-12
Decision Date2013-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851458005044 K131729 000

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