510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113420Substantially Equivalent

Rnaretain

Asuragen, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113420 is the FDA 510(k) clearance record for RNARETAIN, a class II device, cleared for Asuragen, Inc. on under FDA product code OZF (Tissue Rna Preservative For Collection, Storage, And Transportation). FDA's definition for product code OZF reads: "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...". FDA records list 3 510(k) clearances for Asuragen, Inc., from to . As of , FDA records show no recalls naming K113420.

Clearance record

Decision date
Received
(119 days to decision)
Product code
OZF Tissue Rna Preservative For Collection, Storage, And Transportation
Regulation
21 CFR 866.4070
Device class
Class II
Review panel
Immunology
Applicant
Asuragen, Inc. 2150 Woodward St., Suite 100, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZF

Trailing 12 months

FDA records hold no clearances under product code OZF in the trailing twelve months.

FDA records show no clearances under product code OZF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260