Cleared Traditional

RNARETAIN

K113420 · Asuragen, Inc. · Pathology
Mar 2012
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K113420 is an FDA 510(k) clearance for the RNARETAIN, a Tissue Rna Preservative For Collection, Storage, And Transportation (Class II — Special Controls, product code OZF), submitted by Asuragen, Inc. (Austin, US). The FDA issued a Cleared decision on March 16, 2012, 119 days after receiving the submission on November 18, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4070.

Submission Details

510(k) Number K113420 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2011
Decision Date March 16, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OZF — Tissue Rna Preservative For Collection, Storage, And Transportation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.4070
Definition The Human Tissue Rna Preservation Collection, Storage, And Transportation Tube Is A Single-use, Prefilled Container Intended For The Collection, Storage, And Transportation Of Fresh Human Tissue Specimens For Subsequent Rna Isolation And Further Molecular Diagnostic Testing.