Murex Suds Toxo

FDA 510(k) K861458 · Murex Corp.

Substantially Equivalent

510(k) numberK861458

Submission

Device name
Murex Suds Toxo
Applicant
Murex Corp.
Norcross, GA, US
Received
April 18, 1986
Decision date
June 13, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3780
Specialty
Microbiology

Other 510(k)s with product code LGD

510(k)DeviceApplicantDecision
K242022Access Toxo IgGLGD · Traditional Beckman Coulter, Inc.03/28/2025SE
K242095Access Toxo IgM IILGD · Traditional Beckman Coulter, Inc.10/11/2024SE
K233932Alinity i Toxo IgMLGD · Traditional Abbott Laboratories08/30/2024SE
K210596ARCHITECT Toxo IgGLGD · Traditional Abbott Laboratories05/19/2022SE
K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlLGD · Traditional Roche Diagnostics06/23/2017SE
K142826ADVIA Centaur Toxoplasma M (Toxo M)LGD · Traditional Siemens Healthcare Diagnostics, Inc.12/22/2015SE
K132234Liaison(R) Toxo Igg II, Liaison(R) Control Toxo Igg IILGD · Traditional DiaSorin, Inc.08/28/2013SE
K131441Liaison Toxo Igm II, Liaison Control Toxo Igm IILGD · Traditional DiaSorin, Inc.08/09/2013SE
K101946Vidas Toxo Igg AvidityLGD · Traditional bioMerieux, Inc.05/18/2011SE
K102681Advia Centaur Toxoplasma Igg (Toxo G)LGD · Traditional Siemens Healthcare Diagnostics, Inc.05/04/2011SE

More from Siemens Healthcare Diagnostics, Inc.

510(k)DeviceDecision
K862048Suds(Hcg)Control Set (Urine&Serum) & HCG Ref.SerumDQX · Traditional 06/19/1986SE
K861282Murex Suds RubellaLFX · Traditional 06/13/1986SE
K860451Murex (TM), Suds (TM), HCG AssayLCX · Traditional 04/21/1986SE
K860576Murex Suds Group a StrepGTZ · Traditional 04/04/1986SE

Questions and answers

When was Murex Suds Toxo cleared by the FDA?

Murex Suds Toxo (K861458) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 56 days after the submission was received.

What is the product code of K861458?

The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.