Mesacup Test Mpo, Model 11053
FDA 510(k) K040586 · Rhigene, Inc.
510(k) numberK040586
Submission
- Device name
- Mesacup Test Mpo, Model 11053
- Applicant
- Rhigene, Inc.
Westminster, CO, US - Received
- March 5, 2004
- Decision date
- March 22, 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 |
|---|---|---|
| K040711 | Mesacup Test PR-3MOB · Traditional | 04/02/2004SE |
| K040200 | MESACUP-2 Test Cenp-BLJM · Traditional | 03/04/2004SE |
| K033528 | MESACUP-2 Test JO-1, Model 10756LLL · Traditional | 12/22/2003SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | 09/26/2003SE |
| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | 08/14/2002SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | 07/05/2002SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | 04/11/2002SE |
| K000336 | Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 ENBO · Traditional | 06/09/2000SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | 05/09/2000SE |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | 05/09/2000SE |
Questions and answers
When was Mesacup Test Mpo, Model 11053 cleared by the FDA?
Mesacup Test Mpo, Model 11053 (K040586) received a 510(k) decision of Substantially Equivalent on March 22, 2004, 17 days after the submission was received.
What is the product code of K040586?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.