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510(k) DEN110012

Device
APTIMA TRICHOMONAS VAGINALIS ASSAY
Applicant
Gen-Probe Incorporated
510(k) number
DEN110012
Product code
OUY
Decision
Unknown (DENG)
Decision date
2011-04-19
Date received
2011-04-13
Regulation
866.3860
Classification name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
MARIA CARMELITA S BALUYOT
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OUY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231316Aptima Trichomonas vaginalis AssayHologic, Inc.2023-11-06
K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company2019-01-08
K151589BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company2016-09-06
K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid2016-08-29
K161182Solana Trichomonas AssayQuidel Corporation2016-08-15
K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection KitCepheid2015-10-16
K143329AmpliVue Trichomonas AssayQuidel Corporation2015-03-17
K130268BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2013-08-23
K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-09