EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
FDA 510(k) K172582 · Euroimmun Us, Inc.
510(k) numberK172582
Submission
- Device name
- EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- Applicant
- Euroimmun Us, Inc.
Mountain Lakes, NJ, US - Received
- August 28, 2017
- Decision date
- May 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K092600 | Immulisa PR3 Antibody ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional | 09/17/2020SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | 02/28/2019SE |
| 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 IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern cleared by the FDA?
EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern (K172582) received a 510(k) decision of Substantially Equivalent on May 24, 2018, 269 days after the submission was received.
What is the product code of K172582?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.