Varelisa Mpo Anca, Model 17648/17696
FDA 510(k) K041040 · Sweden Diagnostics (Germany) GmbH
510(k) numberK041040
Submission
- Device name
- Varelisa Mpo Anca, Model 17648/17696
- Applicant
- Sweden Diagnostics (Germany) GmbH
Freiburg, DE - Received
- April 22, 2004
- Decision date
- June 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | Zeus Scientific | 08/21/2026SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | Zeus Scientific | 05/07/2025SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | Euroimmun Us, Inc. | 05/24/2018SE |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | Aesku.Diagnostics GmbH & Co. KG | 03/23/2018SE |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB · Traditional | Phadia AB | 03/13/2018SE |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional | Inova Diagnostics, Inc. | 02/03/2017SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | Phadia US, Inc. | 10/27/2014SE |
| K112545 | Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional | Inova Diagnostics, Inc. | 07/31/2012SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | Biomedical Diagnostics (Bmd) SA | 11/03/2010SE |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
More from Immco Diagnostics, 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 |
| K041174 | Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196MVM · Traditional | 07/19/2004SE |
| K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896MST · Traditional | 07/16/2004SE |
Questions and answers
When was Varelisa Mpo Anca, Model 17648/17696 cleared by the FDA?
Varelisa Mpo Anca, Model 17648/17696 (K041040) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 55 days after the submission was received.
What is the product code of K041040?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.