Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga.
FDA 510(k) K002107 · Scimedx Corp.
510(k) numberK002107
Submission
- Device name
- Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga.
- Applicant
- Scimedx Corp.
Denvill, NJ, US - Received
- July 12, 2000
- Decision date
- August 4, 2000
- 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
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 |
|---|---|---|
| K011348 | Phase II GBM Igg Antibody Eia TestMVJ · Traditional | 06/25/2001SE |
| K011082 | Tpo Igg Antibody Eia TestJZO · Traditional | 06/06/2001SE |
| K010625 | Eurospital Eu-Ttg Iga UmanaMVM · Traditional | 04/24/2001SE |
| K010287 | Scimedx Phase II PR3 Igg Antibody EiaMOB · Traditional | 03/16/2001SE |
| K010289 | Scimedx Phase II Mpo Igg Antibody EiaMOB · Traditional | 03/07/2001SE |
| K002189 | Gliadin Igg Antibody Eia Detection SystemMST · Traditional | 10/19/2000SE |
| K002169 | Gliadin Iga Antibody Eia Detection SystemMST · Traditional | 10/19/2000SE |
| K994379 | Eu-Ttg Iga ElisaMVM · Traditional | 02/18/2000SE |
| K970198 | Ifa HEP2 Kit for the Detection of Antinuclear AntibodiesDHN · Traditional | 02/20/1997SE |
| K962360 | Ifa Kit for the Detection of C-Anca AntibodiesMOB · Traditional | 09/30/1996SE |
Questions and answers
When was Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga. cleared by the FDA?
Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga. (K002107) received a 510(k) decision of Substantially Equivalent on August 4, 2000, 23 days after the submission was received.
What is the product code of K002107?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.