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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.
K221925
07/01/2022
ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc.
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