Autostat II Anti-Gliadin Igg Elisa
FDA 510(k) K993087 · Cogent Diagnotics , Ltd.
510(k) numberK993087
Submission
- Device name
- Autostat II Anti-Gliadin Igg Elisa
- Applicant
- Cogent Diagnotics , Ltd.
Midlothian, Scotland, GB - Received
- September 15, 1999
- Decision date
- November 12, 1999
- 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 |
| 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 |
|---|---|---|
| K003057 | Autostat II ENA-4 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K003054 | Autostat II ENA-6 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional | 09/28/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | 02/03/2000SE |
| K993085 | Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional | 02/01/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | 12/06/1999SE |
| K992449 | Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional | 11/24/1999SE |
| K993086 | Autostat II Anti-Gliadin Iga ElisaMST · Traditional | 11/12/1999SE |
| K992440 | Autostat II Anti-Cardiolipin Igg ElisaMID · Traditional | 09/21/1999SE |
Questions and answers
When was Autostat II Anti-Gliadin Igg Elisa cleared by the FDA?
Autostat II Anti-Gliadin Igg Elisa (K993087) received a 510(k) decision of Substantially Equivalent on November 12, 1999, 58 days after the submission was received.
What is the product code of K993087?
The FDA product code is MST – Antibodies, Gliadin, a Class II (moderate risk) device regulated under 21 CFR 866.5750.