ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0— 510(k) K262747
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K262747 for ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0, Substantially Equivalent on 2026-08-31. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Summary
Abbott Diagnostics Scarborough's submission lists four ID NOW tests: Influenza A & B 2, RSV, Strep A 2, and COVID-19 2.0. They're filed under product code OCC, respiratory virus panel nucleic acid assay systems.
Class II, 21 CFR 866.3980. Microbiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Abbott filed from Scarborough, Maine. The decision came 28 calendar days after receipt (August 3 to August 31, 2026), and the record lists it as substantially equivalent.
Clearance details
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Product code
- Product code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Recent devices under product code OCC
view allMore clearances from Abbott Diagnostics Scarborough, Inc.
view allAdverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.