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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261347

510(k) cleared

DASH Flu A/B Test

Nuclein, LLC · Oct 21, 2026 · K261347

FDA cleared the DASH Flu A/B Test from Nuclein, LLC on Oct 21, 2026 under K261347, a dual track 510(k). The device falls under product code OCC, Respiratory Virus Panel Nucleic Acid Assay System, regulated at 21 CFR 866.3980 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Apr 24, 2026. The decision came 180 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nuclein, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261347?

K261347 is the FDA 510(k) for DASH Flu A/B Test, submitted by Nuclein, LLC. FDA's decision date was Oct 21, 2026, under product code OCC (Respiratory Virus Panel Nucleic Acid Assay System).

Who makes the DASH Flu A/B Test?

Nuclein, LLC, based in Austin, TX, is the applicant of record for K261347.

How long did the K261347 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Oct 21, 2026, 180 days later.

← All decisions in October 2026