JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123

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 Plaque Detection Kit, Model Jrpd-asy-0123.

Pre-market Notification Details

Device IDK072631
510k NumberK072631
Device Name:JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
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 Number866.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-18
Decision Date2007-12-20
Summary:summary

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