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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262156

510(k) cleared

Anti-HCV Next

Abbott Laboratories · Sep 23, 2026 · K262156

FDA cleared the Anti-HCV Next from Abbott Laboratories on Sep 23, 2026 under K262156, a traditional 510(k). The device falls under product code MZO, Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus, regulated at 21 CFR 866.3169 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 26, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Abbott Laboratories has one other decision in the tracker over the last 12 months: K252424 (Anti-HCV Next).

Questions & Answers

What did FDA clear under K262156?

K262156 is the FDA 510(k) for Anti-HCV Next, submitted by Abbott Laboratories. FDA's decision date was Sep 23, 2026, under product code MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus).

Who makes the Anti-HCV Next?

Abbott Laboratories, based in Abbott Park, IL, is the applicant of record for K262156.

How long did the K262156 review take?

FDA received the submission on Jun 26, 2026 and issued its decision on Sep 23, 2026, 89 days later.

← All decisions in September 2026

Sources