510(k) K163569
- Device
- Elecsys CMV IgM
- Applicant
- Roche Diagnostics
- 510(k) number
- K163569
- Product code
- LFZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-17
- Date received
- 2016-12-19
- Regulation
- 866.3175
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Angelo Pereira
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3032705
- 2243471
- 3006198300
- 3002800697
- 2090110
- 2245285
- 3005333358
- 2432235
- 3022178699
- 1641328
- 2915274
- 3008344661
- 3002809144
- 9612316
- 1181055
- 2020726
- 1318354
- 1036362
- 1827821
- 8031673
- 2242436
- 1219913
- 9610240
- 3005529799
- 9610126
- 2029372
- 3002806944
- 3007208259
- 8020790
Source Documents#
Other 510(k) Records For Product Code LFZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220949 | Architect CMV IgG | Abbott Laboratories | 2022-10-27 |
| K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022-10-12 |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | Siemens Healthcare Diagnostics, Inc. | 2018-07-30 |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | DiaSorin, Inc. | 2017-01-06 |
| K142133 | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM | Roche Diagnostics | 2014-10-24 |
| K131605 | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY | Roche Diagnostics | 2014-02-28 |
| K040290 | DIASORIN LIAISON CMV IGM/IGG | Diasorin S.P.A | 2005-06-01 |
| K993952 | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 | Diagnostic Products Corp. | 1999-12-16 |
| K982485 | SERAQUEST CMV IGM | Quest Intl., Inc. | 1999-01-13 |
| K984139 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1999-01-11 |
| K983803 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-12-14 |
| K982027 | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY | DiaSorin, Inc. | 1998-11-25 |
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | Diamedix Corp. | 1998-09-21 |
| K971335 | QUANTA LITE CMV IGG ELISA | Inova Diagnostics, Inc. | 1997-12-01 |
| K954301 | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) | Abbott Laboratories | 1997-03-24 |
Legacy Summary#
summary
FDA Review#
Decision Summary