510(k) K113420
K113420 is an FDA 510(k) premarket notification submitted by Asuragen, Inc. for the device "RNARETAIN". The FDA issued a decision of Substantially Equivalent on March 16, 2012. The device falls under product code OZF (Tissue Rna Preservative For Collection, Storage, And Transportation), a Class II device regulated under 21 CFR 866.4070. Asuragen, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2012
- Date Received
- November 18, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Rna Preservative For Collection, Storage, And Transportation
- Device Class
- Class II
- Regulation Number
- 866.4070
- Review Panel
- PA
- Submission Type
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.