510(k) K041173
- Device
- CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
- Applicant
- SWEDEN DIAGNOSTICS (GERMANY) GMBH
- 510(k) number
- K041173
- Product code
- MVM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-02
- Date received
- 2004-05-05
- Regulation
- 866.5660
- Classification name
- Autoantibodies, Endomysial(tissue Transglutaminase)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL LINSS
- Address
- Munzingerstrasse 7 Freiburg DE D-79111 D-79111
FDA Registration Numbers#
- 8043792
- 2242436
- 1421346
- 3003825930
- 3022178699
- 3032705
- 9680745
- 3007361513
- 2032839
- 3012348571
- 9610566
- 3015376545
- 2915274
- 2026994
- 3003268355
- 1222302
- 3004973408
- 9615139
- 3007118747
Source Documents#
Other 510(k) Records For Product Code MVM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021-08-26 |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | 2021-06-16 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Phadia AB | 2019-03-01 |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. | 2019-02-28 |
| K140691 | IG_PLEX CELIAC DGP PANEL | Sqi Diagnostics Systems, Inc. | 2014-11-06 |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2013-10-25 |
| K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| K102490 | IGX PLEX CELIAC QUALITATIVE ASSAY | Sqi Diagnostics Systems | 2011-06-02 |
| K101644 | QUANTA FLASH H-TTG IGG | Inova Diagnostics, Inc. | 2011-03-23 |
| K102964 | EU-TTG IGA AND EU-TTG IGG | Grifols USA, Inc. | 2011-03-07 |
| K094060 | QUANTA FLASH H-TTG IGA | Inova Diagnostics, Inc. | 2010-10-13 |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-03-10 |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | 2008-02-12 |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | 2008-02-11 |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | 2008-01-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary