Asuragen, Inc.

Austin, TX, US

ASURAGEN, INC. appears in FDA device records in Austin, TX. FDA records list 3 510(k) clearances between 2012-03-16 and 2020-02-21, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Asuragen, Inc. between 2012 and 2020. The busiest year on record is 2012, with 1. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Asuragen, Inc., by decision year
Year	Clearances
2012	1
2016	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
DEN190023	AmplideX Fragile X Dx & Carrier Screen Kit	OYV	Unknown	2020-02-21
DEN160003	Quantidex qPCR BCR-ABL IS Kit	OYX	Unknown	2016-07-22
K113420	RNARETAIN	OZF	Substantially Equivalent	2012-03-16

Registered establishments

FDA registered establishments for Asuragen, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3003436513	3003436513	ASURAGEN, INC.	2150 WOODWARD ST, AUSTIN, TX 78744 US	2026	OYV OYX OZF PPM PTA

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain