Visuwell Syphilis Antigen

FDA 510(k) K910487 · Adi Diagnostics, Inc.

Substantially Equivalent

510(k) numberK910487

Submission

Device name
Visuwell Syphilis Antigen
Applicant
Adi Diagnostics, Inc.
Rexdale, Ontario, CA
Received
February 6, 1991
Decision date
June 24, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3830
Specialty
Microbiology

Other 510(k)s with product code LIP

510(k)DeviceApplicantDecision
K241427Access SyphilisLIP · Traditional Beckman Coulter, Inc.09/06/2024SE
K241534VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional Ortho Clinical Diagnostics08/28/2024SE
K211302Elecsys SyphilisLIP · Traditional Roche Diagnostics07/20/2021SE
K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional Bio-Rad Laboratories05/11/2017SE
K160910Elecsys SyphilisLIP · Traditional Roche Diagnostics07/28/2016SE
K153145Lumipulse G TP-N Immunoreaction Cartridge SetLIP · Traditional Fujirebio Diagnostics,Inc.07/05/2016SE
K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…LIP · Traditional Abbott Laboratories06/15/2016SE
K120439Bioplex 2200 Ebv Igg and Syphilis IggLIP · Special Bio-Rad Laboratories, Inc.03/14/2012SE
K112343Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsLIP · Traditional Siemens Healthcare Diagnostics, Inc.01/20/2012SE
K102400Syphilis Health CheckLIP · Traditional Diagnostics Direct, LLC08/01/2011SE

More from Diagnostics Direct, LLC

510(k)DeviceDecision
K900973Visuwell(R) ChlamydiaLJC · Traditional 05/15/1990SE
K900338Visuwell(R) Reagin Test (Modification)GMQ · Traditional 04/10/1990SE
K890840Visuwell Group a Streptococcus Detection KitGTZ · Traditional 03/27/1989SE

Questions and answers

When was Visuwell Syphilis Antigen cleared by the FDA?

Visuwell Syphilis Antigen (K910487) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 138 days after the submission was received.

What is the product code of K910487?

The FDA product code is LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.