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Company-Registration
1428302064
Device Listing 1428302064
Listing Summary
#
Listing key
1428302064
Premarket submission
K243518
Device
BinaxNOW™ COVID-19 Antigen Self Test
Applicant
Abbott Diagnostics Scarborough, Inc.
Product code
QYT
Decision date
2025-02-11
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
346858
3017662853
3017662853
Abbott Diagnostics Scarborough, Inc.
1
N
2026-01-01
5 Bradley Dr Westbrook ME US 04092