Varelisa Gliadin Igg Antibodies
FDA 510(k) K041357 · Sweden Diagnostics (Germany) GmbH
510(k) numberK041357
Submission
- Device name
- Varelisa Gliadin Igg Antibodies
- Applicant
- Sweden Diagnostics (Germany) GmbH
Freiburg, DE - Received
- May 20, 2004
- Decision date
- August 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K132082 | Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional | Aesku Diagnostics | 12/05/2013SE |
| 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 |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | 04/26/2005SE |
| K042629 | Varelisa SM Antibodies, Model 18296LKP · Traditional | 12/08/2004SE |
| K041173 | Celikey Igg Itg Igg Antibodies, Model 17996MVM · Traditional | 08/02/2004SE |
| K041174 | Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196MVM · Traditional | 07/19/2004SE |
| K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896MST · Traditional | 07/16/2004SE |
| K041040 | Varelisa Mpo Anca, Model 17648/17696MOB · Traditional | 06/16/2004SE |
Questions and answers
When was Varelisa Gliadin Igg Antibodies cleared by the FDA?
Varelisa Gliadin Igg Antibodies (K041357) received a 510(k) decision of Substantially Equivalent on August 2, 2004, 74 days after the submission was received.
What is the product code of K041357?
The FDA product code is MST – Antibodies, Gliadin, a Class II (moderate risk) device regulated under 21 CFR 866.5750.