FDA cleared the ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 from Abbott Diagnostics Scarborough, Inc. on Aug 31, 2026 under K262747, a special 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 Aug 3, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Abbott Diagnostics Scarborough, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K262747?
K262747 is the FDA 510(k) for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0, submitted by Abbott Diagnostics Scarborough, Inc.. FDA's decision date was Aug 31, 2026, under product code OCC (Respiratory Virus Panel Nucleic Acid Assay System).
Who makes the ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0?
Abbott Diagnostics Scarborough, Inc., based in Scarborough, ME, is the applicant of record for K262747.
How long did the K262747 review take?
FDA received the submission on Aug 3, 2026 and issued its decision on Aug 31, 2026, 28 days later.