510(k) clearances

Aptima SARS-CoV-2 Assay

Hologic, Inc. · Microbiology

K243396Substantially EquivalentTraditionalQQX
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Microbiology
Address 1
10210 Genetic Center Dr.
Statement or summary
Summary
Product code
QQX
Zip code
92121
Applicant
Hologic, Inc.
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
Aptima SARS-CoV-2 Assay
Advisory committee
MI
Contact
Katerina Capkova
K number
K243396
State
CA
Date received
2024-10-31
Review advisory committee
MI
Postal code
92121
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Medical specialty description
Microbiology
Regulation number
866.3981
Device class
2
Registration number
3009976420, 3021140368, 3004530258, 2024800, 3007420875, 2243471, 3006247421, 3016838963, 1119779, 3009613136, 3010770794, 3004141078
FEI number
3009976420, 3021140368, 3004530258, 2024800, 3007420875, 2243471, 3006247421, 3016838963, 1119779, 3009613136, 3010770794, 3004141078
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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.