Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196
FDA 510(k) K041174 · Sweden Diagnostics (Germany) GmbH
510(k) numberK041174
Submission
- Device name
- Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196
- Applicant
- Sweden Diagnostics (Germany) GmbH
Freiburg, DE - Received
- May 5, 2004
- Decision date
- July 19, 2004
- 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 |
|---|---|---|
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | 04/26/2005SE |
| K042629 | Varelisa SM Antibodies, Model 18296LKP · Traditional | 12/08/2004SE |
| K041357 | Varelisa Gliadin Igg AntibodiesMST · Traditional | 08/02/2004SE |
| K041173 | Celikey Igg Itg Igg Antibodies, Model 17996MVM · Traditional | 08/02/2004SE |
| K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896MST · Traditional | 07/16/2004SE |
| K041040 | Varelisa Mpo Anca, Model 17648/17696MOB · Traditional | 06/16/2004SE |
Questions and answers
When was Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 cleared by the FDA?
Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 (K041174) received a 510(k) decision of Substantially Equivalent on July 19, 2004, 75 days after the submission was received.
What is the product code of K041174?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.