GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

Quality Control Material, Genetics, Dna

GENTRIS CORPORATION

The following data is part of a premarket notification filed by Gentris Corporation with the FDA for Gentrisure Human Genomic Dna Reference Control.

Pre-market Notification Details

Device IDK063224
510k NumberK063224
Device Name:GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
ClassificationQuality Control Material, Genetics, Dna
Applicant GENTRIS CORPORATION 133 SOUTHCENTER CT. SUITE 400 Morrisville,  NC  27560
ContactDeborah N Kloos
CorrespondentDeborah N Kloos
GENTRIS CORPORATION 133 SOUTHCENTER CT. SUITE 400 Morrisville,  NC  27560
Product CodeNZB  
CFR Regulation Number866.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-24
Decision Date2006-12-22

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