510(k) K221925

Device: ID NOW COVID-19 2.0
Applicant: Abbott Diagnostics Scarborough, Inc.
510(k) number: K221925
Product code: QWR
Decision: Substantially Equivalent (SESE)
Decision date: 2023-08-10
Date received: 2022-07-01
Regulation: 866.3982
Classification name: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Dual Track
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00811877011361	ID NOW COVID-19 2.0 Control Swab Kit	Alere Scarborough, Inc.	2022-09-09
00811877011354	ID NOW COVID-19 2.0	Alere Scarborough, Inc.	2022-09-09

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243346	cobas liat SARS-CoV-2 v2 nucleic acid test	Roche Molecular Systems, Inc.	2025-04-11
K223783	cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System	Roche Molecular Systems, Inc.	2023-12-04