IS-ANTI-PR3 Igg Elisa Test System
FDA 510(k) K983740 · Columbia Bioscience, Inc.
510(k) numberK983740
Submission
- Device name
- IS-ANTI-PR3 Igg Elisa Test System
- Applicant
- Columbia Bioscience, Inc.
Columbia, MD, US - Received
- October 22, 1998
- Decision date
- November 18, 1998
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | 09/03/1999SE |
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | 09/03/1999SE |
| K984228 | Is Anti-Tpo Igg Elisa Test SystemJZO · Traditional | 02/02/1999SE |
| K983606 | Is Borrelia Burgdorferi Igm Test SystemLSR · Traditional | 12/16/1998SE |
| K983605 | Is Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 12/16/1998SE |
| K983553 | Anti-Tg Igg Elisa Test SystemJZO · Traditional | 12/07/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | 11/25/1998SE |
| K983390 | Is-Anti-Mpo Igg Elisa Test SystemMOB · Traditional | 11/18/1998SE |
Questions and answers
When was IS-ANTI-PR3 Igg Elisa Test System cleared by the FDA?
IS-ANTI-PR3 Igg Elisa Test System (K983740) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 27 days after the submission was received.
What is the product code of K983740?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.