FDA 510(k) Applications Submitted by Abbott Diagnostics Scarborough, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K191534 06/10/2019 ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc.
K220801 03/18/2022 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 Abbott Diagnostics Scarborough, Inc.
K232775 09/11/2023 ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc.
K221925 07/01/2022 ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc.
K250273 01/30/2025 BinaxNOW COVID-19 Ag Card Abbott Diagnostics Scarborough, Inc.
K243518 11/13/2024 BinaxNOWÖ COVID-19 Antigen Self Test; BinaxNOWÖ COVID-19 Ag Card Abbott Diagnostics Scarborough, Inc.


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