FDA.report

510(k) K231329

Device
Aptima Neisseria gonorrhoeae Assay
Applicant
Hologic, Inc.
510(k) number
K231329
Product code
LSL
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-26
Date received
2023-05-08
Regulation
866.3390
Classification name
Dna-Reagents, Neisseria
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jon Kukowski
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code LSL

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K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.2018-06-13
K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.2018-03-21
K173840Xpert CT/NGCepheid2018-03-16
K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.2017-02-09
K140448BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2014-05-20
K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGAbbott Molecular, Inc.2014-05-09
K140887COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.2014-05-05
K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.2013-12-02
K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated2013-10-17
K121710XPERT CT/NGCepheid2012-12-27
K111409APTIMA COMBO 2 ASSAYGen-Probe, Inc.2012-05-03
K091730BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-11-13
K090971BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-06-05
K090827BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-05-27
K081825BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2008-12-11