510(k) K163177
- Device
- ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- Applicant
- IMMCO DIAGNOSTICS, INC.
- 510(k) number
- K163177
- Product code
- MST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-28
- Date received
- 2016-11-14
- Regulation
- 866.5750
- Classification name
- Antibodies, Gliadin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN LAWSON
- Address
- 9870 Hollingson Rd. Clarence NY US 14031 14031
FDA Registration Numbers#
- 8043792
- 2242436
- 1421346
- 3003825930
- 3022178699
- 3032705
- 9680745
- 3002800697
- 3007361513
- 2029372
- 2245285
- 2032839
- 3012348571
- 9610566
- 2915274
- 2026994
- 3003268355
- 3004973408
- 9615139
- 3007118747
Source Documents#
Other 510(k) Records For Product Code MST #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | Aesku Diagnostics | 2013-12-05 |
| K113377 | GLIADIN IGA AND GLIADIN LGA | Grifols USA, LLC | 2012-12-14 |
| K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS | Inova Diagnostics, Inc. | 2012-09-20 |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | Inova Diagnostics, Inc. | 2011-10-20 |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 | Phadia US, Inc. | 2010-08-13 |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-02-04 |
| K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | Euroimmun Us, Inc. | 2009-08-07 |
| K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | Euroimmun Us, Inc. | 2009-07-28 |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | The Binding Site, Ltd. | 2008-10-15 |
| K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | Phadia US, Inc. | 2007-03-14 |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | Inova Diagnostics, Inc. | 2007-03-12 |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | Inova Diagnostics, Inc. | 2006-12-13 |
| K053383 | FIDIS CELIAC | Biomedical Diagnostics (Bmd) SA | 2006-03-29 |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | Aesku Diagnostics | 2006-02-07 |
| K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 | Pharmacia Diagnostics AB | 2006-02-07 |
Legacy Summary#
summary
FDA Review#
Decision Summary