Varelisa PR3 Anca, Model Number 17748/17796
FDA 510(k) K041043 · Pharmacia Deutschland GmbH
510(k) numberK041043
Submission
- Device name
- Varelisa PR3 Anca, Model Number 17748/17796
- Applicant
- Pharmacia Deutschland GmbH
Freiburg Im Breisgau, DE - Received
- April 22, 2004
- Decision date
- July 2, 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 |
|---|---|---|
| K040810 | Varelisa Histone Antibodies, Model 16496LJM · Traditional | 05/14/2004SE |
| K040811 | Varelisa Ssdna Antibodies, Model 14896LRM · Traditional | 05/13/2004SE |
| K040452 | Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional | 05/11/2004SE |
| K040451 | Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896MSV · Traditional | 05/11/2004SE |
| K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996MSV · Traditional | 05/11/2004SE |
| K040449 | Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796MSV · Traditional | 05/11/2004SE |
| K020758 | Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696MID · Traditional | 05/02/2002SE |
| K020757 | Varelisa Cardiolipin Iga Antibodies, Models 15748 & 15796MID · Traditional | 05/02/2002SE |
| K020752 | Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596MID · Traditional | 05/02/2002SE |
Questions and answers
When was Varelisa PR3 Anca, Model Number 17748/17796 cleared by the FDA?
Varelisa PR3 Anca, Model Number 17748/17796 (K041043) received a 510(k) decision of Substantially Equivalent on July 2, 2004, 71 days after the submission was received.
What is the product code of K041043?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.