ID NOW COVID-19 2.0— 510(k) K221925

Substantially Equivalent

Abbott Diagnostics Scarborough, Inc.

FDA 510(k) clearance K221925 for ID NOW COVID-19 2.0, Substantially Equivalent on 2023-08-10. Applicant: Abbott Diagnostics Scarborough, Inc..

Clearance details

Applicant: Abbott Diagnostics Scarborough, Inc.
Product code: Code QWR
Advisory panel: Microbiology
Date received: 2022-07-01
Decision date: 2023-08-10
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Scarborough, ME, US

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