Medical Device Manufacturer · US , Scarborough , ME

Abbott Diagnostics Scarborough, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2019

Recent clearances: BinaxNOW COVID-19 Ag Card, BinaxNOW™ COVID-19 Antigen Self Test, ID NOW Influenza A & B 2

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Diagnostics Scarborough, Inc. Microbiology ✕

6 devices

1-6 of 6

Cleared Jun 13, 2025

BinaxNOW COVID-19 Ag Card

Microbiology · 134d

Cleared Feb 11, 2025

BinaxNOW™ COVID-19 Antigen Self Test

Microbiology · 90d

Cleared Oct 10, 2023

ID NOW Influenza A & B 2

Microbiology · 29d

Cleared Aug 10, 2023

ID NOW COVID-19 2.0

Microbiology · 405d

Cleared Jun 24, 2022

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

Microbiology · 98d

Cleared Jul 11, 2019

ID NOW Influenza A & B 2

Microbiology · 31d