510(k) clearances

BinaxNOW™ COVID-19 Antigen Self Test

Abbott Diagnostics Scarborough, Inc. · Microbiology

K243518Substantially EquivalentTraditionalQYT
Open FDA's page for this record
Third party flag
N
City
Scarborough
Advisory committee description
Microbiology
Address 1
10 Southgate Rd.
Statement or summary
Summary
Product code
QYT
Zip code
04074
Applicant
Abbott Diagnostics Scarborough, Inc.
Decision date
2025-02-11
Decision code
SESE
Country code
US
Device name
BinaxNOW™ COVID-19 Antigen Self Test
Advisory committee
MI
Contact
Kristen Cyr
K number
K243518
State
ME
Date received
2024-11-13
Review advisory committee
MI
Postal code
04074
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Over-The-Counter Covid-19 Antigen Test
Medical specialty description
Microbiology
Regulation number
866.3984
Device class
2
Registration number
3008517993, 1528450, 3008573045, 3031823359, 3024756665, 3033751096, 3030648160, 3028107593, 3032562, 3004635103, 3014660585, 3016609999, 3038560224, 2531491, 3017662853, 9615507, 3021090658, 3009238284, 3007606081, 3020885868, 3032171519, 3013160357, 3023322455, 3017550662, 3004146366, 3009585529
FEI number
3008517993, 3008573045, 3031823359, 3024756665, 3033751096, 3030648160, 3028107593, 3004635103, 3014660585, 3016609999, 3038560224, 3002829675, 3003516723, 3017662853, 3021090658, 3009238284, 3007606081, 3020885868, 3032171519, 3013160357, 3023322455, 3017550662, 3004146366, 3009585529, 3002606748, 1000122536
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.