Medical Device Manufacturer · US , Austin , TX

Asuragen, Inc.

3 submissions · 1 cleared · Since 2012
3
Total
1
Cleared
2
Denied

Asuragen, Inc. — FDA 510(k) Submissions

Asuragen, Inc. has submitted 3 FDA 510(k) premarket notifications since 2012, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bcr/abl1 Monitoring Test, Inherited Nucleotide Repeat Disorder Dna Test, Tissue Rna Preservative For Collection, Storage, And Transportation . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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