RNARETAIN

Tissue Rna Preservative For Collection, Storage, And Transportation

ASURAGEN, INC.

The following data is part of a premarket notification filed by Asuragen, Inc. with the FDA for Rnaretain.

Pre-market Notification Details

Device IDK113420
510k NumberK113420
Device Name:RNARETAIN
ClassificationTissue Rna Preservative For Collection, Storage, And Transportation
Applicant ASURAGEN, INC. 2150 WOODWARD ST. SUITE 100 Austin,  TX  78744 -1840
ContactLuc Van Hove
CorrespondentLuc Van Hove
ASURAGEN, INC. 2150 WOODWARD ST. SUITE 100 Austin,  TX  78744 -1840
Product CodeOZF  
CFR Regulation Number866.4070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-18
Decision Date2012-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863840000285 K113420 000

Trademark Results [RNARETAIN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RNARETAIN
RNARETAIN
77209982 3689865 Live/Registered
Asuragen, Inc.
2007-06-19

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