Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-Check
FDA 510(k) K132082 · Aesku Diagnostics
510(k) numberK132082
Submission
- Device name
- Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-Check
- Applicant
- Aesku Diagnostics
Wendelsheim, Rheinland, DE - Received
- July 5, 2013
- Decision date
- December 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MST – Antibodies, Gliadin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
Other 510(k)s with product code MST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | Immco Diagnostics, Inc. | 07/28/2017SE |
| K113377 | Gliadin Iga and Gliadin LgaMST · Traditional | Grifols USA, LLC | 12/14/2012SE |
| K113863 | Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…MST · Traditional | Inova Diagnostics, Inc. | 09/20/2012SE |
| K111414 | Quanta Flash (TM) DGP ScreenMST · Traditional | Inova Diagnostics, Inc. | 10/20/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | Phadia US, Inc. | 08/13/2010SE |
| K091522 | Immulisa Celiac G+ (Gliadin) Iga and Igg Antibody ElisaMST · Traditional | Immco Diagnostics, Inc. | 02/04/2010SE |
| K083053 | Euroimmun Anti-Gliadin (GAF-3X) Elisa (Igg)MST · Traditional | Euroimmun Us, Inc. | 08/07/2009SE |
| K083052 | Euroimmun Anti-Gliadin (GAF-3X) Elisa (Iga)MST · Traditional | Euroimmun Us, Inc. | 07/28/2009SE |
| K081674 | Bindazyme Human Anti-Gliadin (MGP), Igg Eia Kit; Bindazyme Human Anti-Gliadin (MGP) Iga…MST · Traditional | The Binding Site, Ltd. | 10/15/2008SE |
| K063775 | Elia Gliadin Iga, Igg and Celiac ControlMST · Traditional | Phadia US, Inc. | 03/14/2007SE |
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| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | 02/16/2018SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | 10/15/2012SE |
| K091859 | Aesku PR3MOB · Traditional | 06/03/2010SE |
| K091860 | Aeskulisa Mpo, Model 30-7303USMOB · Traditional | 02/23/2010SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | 05/13/2008SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | 05/02/2008SE |
| K052439 | Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional | 02/07/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | 10/14/2004SE |
| K041753 | Aeskulisa Ena 6 SLLL · Traditional | 07/14/2004SE |
Questions and answers
When was Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-Check cleared by the FDA?
Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-Check (K132082) received a 510(k) decision of Substantially Equivalent on December 5, 2013, 153 days after the submission was received.
What is the product code of K132082?
The FDA product code is MST – Antibodies, Gliadin, a Class II (moderate risk) device regulated under 21 CFR 866.5750.