Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/Igg Elisa
FDA 510(k) K040095 · Immco Diagnostics, Inc.
510(k) numberK040095
Submission
- Device name
- Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/Igg Elisa
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- January 20, 2004
- Decision date
- March 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MVM – Autoantibodies, Endomysial(Tissue Transglutaminase)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | Inova Diagnostics, Inc. | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | Inova Diagnostics, Inc. | 06/16/2021SE |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…MVM · Traditional | Phadia AB | 03/01/2019SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | Euroimmun Us, Inc. | 02/28/2019SE |
| K140691 | Ig_Plex Celiac DGP PanelMVM · Traditional | Sqi Diagnostics Systems, Inc. | 11/06/2014SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | Immco Diagnostics, Inc. | 10/25/2013SE |
| K130053 | Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…MVM · Traditional | Bio-Rad Laboratories, Inc. | 09/19/2013SE |
| K102490 | Igx Plex Celiac Qualitative AssayMVM · Traditional | Sqi Diagnostics Systems | 06/02/2011SE |
| K101644 | Quanta Flash H-Ttg IggMVM · Traditional | Inova Diagnostics, Inc. | 03/23/2011SE |
| K102964 | Eu-Ttg Iga and Eu-Ttg IggMVM · Traditional | Grifols USA, Inc. | 03/07/2011SE |
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| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
Questions and answers
When was Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/Igg Elisa cleared by the FDA?
Immulisa Anti-Human Tissue Transglutaminase (Hu-Ttg) Antibody Total Iga/Igg Elisa (K040095) received a 510(k) decision of Substantially Equivalent on March 5, 2004, 45 days after the submission was received.
What is the product code of K040095?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.