Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01
FDA 510(k) K062787 · Phadia US, Inc.
510(k) numberK062787
Submission
- Device name
- Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- September 18, 2006
- Decision date
- December 29, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code MVM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Grifols USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | 02/13/2015SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | 10/27/2014SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | 08/29/2014SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | 12/23/2013SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | 08/28/2013SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | 09/13/2012SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | 06/22/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | 12/22/2011SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | 09/30/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | 08/13/2010SE |
Questions and answers
When was Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01 cleared by the FDA?
Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01 (K062787) received a 510(k) decision of Substantially Equivalent on December 29, 2006, 102 days after the submission was received.
What is the product code of K062787?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.