510(k) clearance

ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0

FDA 510(k) source

510(k) number

K262747

Applicant

Abbott Diagnostics Scarborough, Inc.

Decision date

Aug 31, 2026

Date received

Aug 3, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

OCC

Device type

Respiratory Virus Panel Nucleic Acid Assay System

Device class

Class II

Regulation

21 CFR 866.3980

Advisory committee

Microbiology

Statement or summary

Summary

Third party

N

Location

Scarborough, ME, US