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 ID: K113420
• 510k Number: K113420
• Device Name: RNARETAIN
• Classification: Tissue Rna Preservative For Collection, Storage, And Transportation
• Applicant: ASURAGEN, INC. 2150 WOODWARD ST. SUITE 100 Austin, TX 78744 -1840
• Contact: Luc Van Hove
• Correspondent: Luc Van Hove; ASURAGEN, INC. 2150 WOODWARD ST. SUITE 100 Austin, TX 78744 -1840
• Product Code: OZF
• CFR Regulation Number: 866.4070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-18
• Decision Date: 2012-03-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00863840000285	K113420	000