EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
FDA 510(k) clearance K083053 · decided 2009-08-07
Clearance details
- K-number
- K083053
- Device name
- EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-14
- Decision date
- 2009-08-07
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- MST
- Device class
- 2
- Regulation number
- 866.5750
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Morristown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA (K163177) | Immco Diagnostics, Inc. | 2017-07-28 |
| AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (K132082) | Aesku Diagnostics | 2013-12-05 |
| GLIADIN IGA AND GLIADIN LGA (K113377) | Grifols USA, LLC | 2012-12-14 |
| QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS (K113863) | Inova Diagnostics, Inc. | 2012-09-20 |
| QUANTA FLASH (TM) DGP SCREEN (K111414) | Inova Diagnostics, Inc. | 2011-10-20 |
| ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 (K093459) | Phadia US, Inc. | 2010-08-13 |
| IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (K091522) | Immco Diagnostics, Inc. | 2010-02-04 |
| EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (K083052) | Euroimmun Us, Inc. | 2009-07-28 |
| BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) (K081674) | The Binding Site, Ltd. | 2008-10-15 |
| ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (K063775) | Phadia US, Inc. | 2007-03-14 |
| QUANTA LITE H-TTG/DGP SCREEN (K070083) | Inova Diagnostics, Inc. | 2007-03-12 |
| QUANTA LITE CELIAC DGP SCREEN (K062708) | Inova Diagnostics, Inc. | 2006-12-13 |
Recalls involving this device
No recalls on record reference this clearance.