FDA.reportPublic FDA data

510(k) K241427

Device
Access Syphilis
Applicant
Beckman Coulter, Inc.
510(k) number
K241427
Product code
LIP
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-06
Date received
2024-05-20
Regulation
866.3830
Classification name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brenda Eifert
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics2024-08-28
K211302Elecsys SyphilisRoche Diagnostics2021-07-20
K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories2017-05-11
K160910Elecsys SyphilisRoche Diagnostics2016-07-28
K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.2016-07-05
K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlAbbott Laboratories2016-06-15
K120439BIOPLEX 2200 EBV IGG AND SYPHILIS IGGBio-Rad Laboratories, Inc.2012-03-14
K112343TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics, Inc.2012-01-20
K102400SYPHILIS HEALTH CHECKDiagnostics Direct, LLC2011-08-01
K102283ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEMZeus Scientific, Inc.2011-02-10
K093837ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEMZeus Scientific, Inc. (Zeus)2010-10-01
K091361IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEMSiemens Healthcare Diagnostics2009-12-16
K063866BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories2007-03-19
K050590ENZY-WELL SYPHILIS IGG, MODEL 91106Diesse Diagnostica Senese S.P.A.2006-08-10
K053570TREP-SURE TREPONEMAL ANTIBODY EIAPhoenix Biotech Corp.2006-08-07