EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
FDA 510(k) K183313 · Euroimmun Us, Inc.
510(k) numberK183313
Submission
- Device name
- EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- Applicant
- Euroimmun Us, Inc.
Mountain Lakes, NJ, US - Received
- November 29, 2018
- Decision date
- February 28, 2019
- 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 |
| 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 |
| K094060 | Quanta Flash H-Ttg IgaMVM · Traditional | Inova Diagnostics, Inc. | 10/13/2010SE |
More from Inova Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional | 09/17/2020SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | 05/24/2018SE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | 12/10/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | 08/25/2016SE |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional | 08/12/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | 08/10/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | 05/04/2015SE |
| K141827 | Euroimmun Ifa 40: HEP-20-10; Europattern Microscope and SoftwareDHN · Traditional | 04/17/2015SE |
Questions and answers
When was EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) cleared by the FDA?
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) (K183313) received a 510(k) decision of Substantially Equivalent on February 28, 2019, 91 days after the submission was received.
What is the product code of K183313?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.