510(k) Report

FDA applicant

Asuragen, Inc.

Austin, TX3 decisions2012–20200 recalls

FDA records 3 decisions for Asuragen, Inc. (Austin, TX) from 2012 to 2020: 1 510(k) clearance and 2 De Novo grants. Most are in product codes OYX (Bcr/Abl1 Monitoring Test) and OZF (Tissue Rna Preservative For Collection…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Asuragen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12016: 12020: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Asuragen, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Asuragen, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OYXBcr/Abl1 Monitoring Test1decision
  • OZFTissue Rna Preservative For Collection, Storage, And Transportation1decision
  • OYVInherited Nucleotide Repeat Disorder Dna Test1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN160003Quantidex qPCR BCR-ABL IS KitAsuragen, Inc. · 20162cite it

What has FDA decided for it lately?

  • DEN190023AmplideX Fragile X Dx & Carrier Screen KitAsuragen, Inc. · 2020
  • DEN160003Quantidex qPCR BCR-ABL IS KitAsuragen, Inc. · 2016
  • K113420RnaretainAsuragen, Inc. · 2012

All 3 as Asuragen, Inc. →