510(k) K113420

Device

RNARETAIN

Applicant

ASURAGEN, INC.

510(k) number

K113420

Product code

OZF  

Decision

Substantially Equivalent (SESE)

Decision date

2012-03-16

Date received

2011-11-18

Regulation

866.4070

Classification name

Tissue Rna Preservative For Collection, Storage, And Transportation

Medical specialty

Immunology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No