Fidis Vasculitis Assay Kit and Analyzer and Caris System
FDA 510(k) K100917 · Biomedical Diagnostics (Bmd) SA
510(k) numberK100917
Submission
- Device name
- Fidis Vasculitis Assay Kit and Analyzer and Caris System
- Applicant
- Biomedical Diagnostics (Bmd) SA
Marne La Vallee Cedex 2, FR - Received
- April 2, 2010
- Decision date
- November 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
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| 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 |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
| K092600 | Immulisa PR3 Antibody ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102607 | Fidistm Connective 10, Fidistm Analyzer, CarisLLL · Traditional | 12/03/2010SE |
| K070458 | Modification to Fidis Vasculitis, Model MX007MOB · Traditional | 12/21/2007SE |
| K071210 | Modification to Fidis Connective 10*, Model MX006LKO · Traditional | 12/19/2007SE |
| K061794 | Fidis TM Thyro, Model MX002JZO · Traditional | 11/21/2006SE |
| K060380 | Fidis DsdnaLSW · Traditional | 05/02/2006SE |
| K053383 | Fidis CeliacMST · Traditional | 03/29/2006SE |
| K053653 | Fidis Connective 10, Model MX006LLL · Traditional | 03/13/2006SE |
| K053012 | Fidis Vasculitis, Model MX007MOB · Traditional | 03/02/2006SE |
| K050286 | Fidis Connective 8LLL · Traditional | 10/03/2005SE |
Questions and answers
When was Fidis Vasculitis Assay Kit and Analyzer and Caris System cleared by the FDA?
Fidis Vasculitis Assay Kit and Analyzer and Caris System (K100917) received a 510(k) decision of Substantially Equivalent on November 3, 2010, 215 days after the submission was received.
What is the product code of K100917?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.