510(k) K162678
- Device
- Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
- Applicant
- ROCHE DIAGNOSTICS
- 510(k) number
- K162678
- Product code
- LGD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-23
- Date received
- 2016-09-26
- Regulation
- 866.3780
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kelli Turner
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3032705
- 3006198300
- 3003030793
- 2090110
- 9615037
- 3005333358
- 2432235
- 3022178699
- 1641328
- 2915274
- 3002809144
- 9612316
- 2020726
- 1318354
- 1036362
- 2122870
- 1827821
- 8031673
- 3024753119
- 3033967997
- 2242436
- 3035708936
- 8020888
- 8023060
- 1219913
- 9610240
- 3005529799
- 9610126
- 2029372
- 3002806944
- 3007208259
- 8020790
Source Documents#
Other 510(k) Records For Product Code LGD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025-03-28 |
| K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | 2024-10-11 |
| K233932 | Alinity i Toxo IgM | Abbott Laboratories | 2024-08-30 |
| K210596 | ARCHITECT Toxo IgG | Abbott Laboratories | 2022-05-19 |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | DiaSorin, Inc. | 2013-08-28 |
| K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | DiaSorin, Inc. | 2013-08-09 |
| K101946 | VIDAS TOXO IGG AVIDITY | bioMerieux, Inc. | 2011-05-18 |
| K102681 | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | Bio-Rad Laboratories | 2009-07-01 |
| K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG | Roche Diagnostics Corp. | 2008-06-09 |
| K080869 | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC | Beckman Coulter, Inc. | 2008-05-23 |
| K052499 | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS | Diasorin S.P.A | 2006-02-08 |
| K032162 | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY | Beckman Coulter, Inc. | 2003-08-08 |
| K031506 | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY | Beckman Coulter, Inc. | 2003-06-02 |
Legacy Summary#
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FDA Review#
Decision Summary