Quanta Lite H-Ttg/Dgp Screen
FDA 510(k) K070083 · Inova Diagnostics, Inc.
510(k) numberK070083
Submission
- Device name
- Quanta Lite H-Ttg/Dgp Screen
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- January 9, 2007
- Decision date
- March 12, 2007
- 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 |
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Questions and answers
When was Quanta Lite H-Ttg/Dgp Screen cleared by the FDA?
Quanta Lite H-Ttg/Dgp Screen (K070083) received a 510(k) decision of Substantially Equivalent on March 12, 2007, 62 days after the submission was received.
What is the product code of K070083?
The FDA product code is MST – Antibodies, Gliadin, a Class II (moderate risk) device regulated under 21 CFR 866.5750.