Mpo Elisa Test System
FDA 510(k) K961765 · Immunoprobe, Inc.
510(k) numberK961765
Submission
- Device name
- Mpo Elisa Test System
- Applicant
- Immunoprobe, Inc.
Frederick, MD, US - Received
- May 7, 1996
- Decision date
- August 19, 1996
- 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 |
|---|---|---|
| K972406 | Adenovirus Antigen Detection Elisa Test SystemGOD · Traditional | 12/22/1997SE |
| K971393 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | 07/14/1997SE |
| K961764 | PR-3 Elisa Test SystemMOB · Traditional | 08/19/1996SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | 04/29/1996SE |
| K952523 | Cardiolipin Igg Eia Test KitMID · Traditional | 02/09/1996SE |
| K952522 | Cardiolipin Iga Eia Test SystemMID · Traditional | 02/09/1996SE |
| K952521 | Cardiolipin Igm Eia Test SystemMID · Traditional | 02/09/1996SE |
| K951364 | Microsomal Eia Test KitJNL · Traditional | 11/20/1995SE |
| K951362 | Thyroglobulin Eia Test KitJNL · Traditional | 11/20/1995SE |
| K951363 | Cardiolipin Igg,M,A Eia Test SystemMID · Traditional | 10/13/1995SE |
Questions and answers
When was Mpo Elisa Test System cleared by the FDA?
Mpo Elisa Test System (K961765) received a 510(k) decision of Substantially Equivalent on August 19, 1996, 104 days after the submission was received.
What is the product code of K961765?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.