Mdi Gliadin a Test
FDA 510(k) K002358 · Micro Detect, Inc.
510(k) numberK002358
Submission
- Device name
- Mdi Gliadin a Test
- Applicant
- Micro Detect, Inc.
Tustin, CA, US - Received
- August 2, 2000
- Decision date
- October 19, 2000
- 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 |
|---|---|---|
| K003794 | Elisa Test, SerologyLYR · Traditional | 03/30/2001SE |
| K002359 | Mdi Gliadin G TestMST · Traditional | 10/19/2000SE |
| K000934 | Mdi SCL-70 TestLJM · Traditional | 04/07/2000SE |
| K000477 | Mdi Ds-Dna TestLRM · Traditional | 03/01/2000SE |
| K994029 | Mdi SM TestLLL · Traditional | 01/11/2000SE |
| K993971 | Mdi Ss-B Test Enzyme Immunoassay for the Detection of Autoantibodies to Ss-B in Human…LLL · Traditional | 01/11/2000SE |
| K993843 | Mdi RF TestDHR · Traditional | 01/11/2000SE |
| K993636 | Mdi Ss-A TestLJM · Traditional | 01/10/2000SE |
| K993635 | Mdi Sm/Rnp TestLJM · Traditional | 01/10/2000SE |
| K973508 | Pylori Detect IggLYR · Traditional | 03/10/1998SE |
Questions and answers
When was Mdi Gliadin a Test cleared by the FDA?
Mdi Gliadin a Test (K002358) received a 510(k) decision of Substantially Equivalent on October 19, 2000, 78 days after the submission was received.
What is the product code of K002358?
The FDA product code is MST – Antibodies, Gliadin, a Class II (moderate risk) device regulated under 21 CFR 866.5750.