JBAIDS ANTHRAC DETECTION SYSTEM

Assay, Nucleic Acid Amplification, Bacillus Anthracis

IDAHO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Jbaids Anthrac Detection System.

Pre-market Notification Details

Device IDK051713
510k NumberK051713
Device Name:JBAIDS ANTHRAC DETECTION SYSTEM
ClassificationAssay, Nucleic Acid Amplification, Bacillus Anthracis
Applicant IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City,  UT  84108
ContactBeth Lingenfelter
CorrespondentBeth Lingenfelter
IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City,  UT  84108
Product CodeNHT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-27
Decision Date2005-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851458005006 K051713 000

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