510(k) clearances

Aptima Neisseria gonorrhoeae Assay

Hologic, Inc. · Microbiology

K231329Substantially EquivalentTraditionalLSL
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
LSL
Zip code
92121
Applicant
Hologic, Inc.
Decision date
2024-01-26
Decision code
SESE
Country code
US
Device name
Aptima Neisseria gonorrhoeae Assay
Advisory committee
MI
Contact
Jon Kukowski
K number
K231329
State
CA
Date received
2023-05-08
Review advisory committee
MI
Postal code
92121
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Dna-Reagents, Neisseria
Medical specialty description
Microbiology
Regulation number
866.3390
Device class
2
Registration number
3012598266, 2024800, 3007420875, 2243471, 3003795116, 3016838963, 3025663244, 3009613136, 2436875, 3006198300, 3026940910, 3004530258, 3013019728, 3018348, 1122376, 3004141078, 3043226252, 1119779, 3012494290, 3038610665, 3019837962, 3005248192, 9610126, 3016608638, 3017907743, 2029275, 1550222, 3002444944
FEI number
3012598266, 2024800, 3007420875, 2243471, 3003795116, 3016838963, 3025663244, 3009613136, 3006198300, 3026940910, 3004530258, 3013019728, 3002806559, 3018348, 1000306431, 3004141078, 1000521444, 3043226252, 1119779, 3012494290, 3038610665, 3019837962, 3005248192, 3003572099, 3016608638, 3017907743, 1550222, 3002444944
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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.